CVA (Cerebrovascular Accident)NCT05311384

Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity

A study testing Keys Constraint-induced Movement Therapy protocol in people with CVA (Cerebrovascular Accident) and Stroke, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: CVA (Cerebrovascular Accident), Stroke, Upper Extremity Paresis
What is being tested?: Keys Constraint-induced Movement Therapy protocol
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 20 Apr 2022to 1 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 6 months after stroke
Ability to demonstrate minimum movement criteria of more-affected UE including 10 degrees of wrist extension (starting from a fully flexed position), 10 degrees of thumb abduction, and 10 degrees of extension of two additional fingers at all joints
Score <2.5 on the MAL indicating significant functional deficits of the more-affected UE

Who cannot join

Inability to answer the MAL questions and/or provide informed consent
Score <24 on the Mini-Mental State Examination
No availability to come to the clinic for the sessions.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity Recovery Following Stroke: A Pilot Study

CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP), and strategies to remind participants to use the more-affected extremity; including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have demonstrated robust evidence for increasing the amount and the quality of the paretic UE functional use in daily situations of individuals recovering from stroke.

Previous studies have explored the barriers for clinical implementation of the approach, including the amount of time needed by therapists, other resources required and lack of payment for the services. With regards to therapists' time/resources, in the signature CI therapy protocol, therapists supervised movement training for 3 hours daily (except for weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for traditional rehabilitation clinical settings. The treatment schedule is also incompatible with most insurance reimbursement policies in the US. As such, most CI therapy clinics require patients to pay privately with little or no insurance reimbursement. Such practices severely limit the number of patients who can afford to receive CI therapy. Two lines of evidence have suggested that an alternative CI therapy protocol may allow for the essential (or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist time/resources and is compatible with payment policies of many US insurance companies. One line of evidence comes from findings that indicate that the original 6-hour supervised training schedule could be shortened to as little as 2-hours/daily without a reduction in outcomes. Additional evidence comes from a study exploring the systematic addition and deletion of the signature CI therapy protocol elements indicated that when the transfer package was omitted, outcomes related to functional use were reduced by 50%. These findings were also verified by brain imaging studies conducted concurrently that revealed a much-reduced level of brain remodeling in those not receiving the transfer package. These findings highlight the potential effectiveness of the transfer package and continued movement training by the patient while away from clinical supervision. The hypothesis of this study is that the amount of supervised training could be reduced further and delivered in a distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over a 12-day treatment period. This modification could be possible by adapting and strengthening the transfer package component of the protocol. In order to investigate if all of the Keys intervention protocol is necessary for producing optimal outcomes, the delivery of specific protocol elements will be also explored. Additionally, another round of testing at the 4-week point of the 8-week intervention will be administered to investigate the need for the final 4 weeks of the intervention.

Conditions: CVA (Cerebrovascular Accident), Stroke, Upper Extremity Paresis
Being tested: Keys Constraint-induced Movement Therapy protocol
Medical subject headings: Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Keys Constraint-induced Movement Therapy protocolBehavioural
All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.

Study groups in NCT05311384
Study group	Role	What they receive
Keys intervention	Experimental	All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Receives: Behavioral: Keys Constraint-induced Movement Therapy protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

Motor Activity Log (MAL)
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Measured: Pre-treatment
Motor Activity Log (MAL)
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Measured: 4 weeks after starting the intervention (middle of the protocol)
Motor Activity Log (MAL)
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment.The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity before and after the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.
Measured: after the intervention (8 weeks after starting the protocol)
Motor Activity Log (MAL)
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Measured: 3 months after the end of the treatment.
Canadian Occupational Performance Measure (COPM)
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Measured: Pre-treatment
Canadian Occupational Performance Measure (COPM)
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Measured: 4 weeks after starting the intervention (middle of the protocol)
Canadian Occupational Performance Measure (COPM)
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Measured: after the intervention (8 weeks after starting the protocol)
Canadian Occupational Performance Measure (COPM)
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Measured: 3 months after the end of the treatment.
Wolf Motor Function Test (WMFT) - Performance Time
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Measured: Pre-treatment
Wolf Motor Function Test (WMFT) - Performance Time
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Measured: 4 weeks after starting the intervention (middle of the protocol)
Wolf Motor Function Test (WMFT) - Performance Time
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Measured: after the intervention (8 weeks after starting the protocol)
Wolf Motor Function Test (WMFT) - Functional Ability Scale
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Measured: Pre-treatment
Wolf Motor Function Test (WMFT) - Functional Ability Scale
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Measured: 4 weeks after starting the intervention (middle of the protocol)
Wolf Motor Function Test (WMFT) - Functional Ability Scale
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Measured: after the intervention (8 weeks after starting the protocol)

Secondary outcomes (8)

Stroke Impact Scale (SIS)
The SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Measured: Pre-treatment
Stroke Impact Scale (SIS)
The SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Measured: 4 weeks after starting the intervention (middle of the protocol)
Stroke Impact Scale (SIS)
The SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Measured: after the intervention (8 weeks after starting the protocol)
Stroke Impact Scale (SIS)
The SIS is a self-reported measure of disability and quality of life after stroke. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment. The SIS includes 9 domains and each one of them ranges from 0-100, where lower score mean more difficulty performing the task and lower self-perceived recovery. The domains are: 1) Strength, 2) Memory; 3) Mood; 4) Communication; 5) Activities of Daily Living (ADLs)/ Instrumental ADLs (IADLs); 6) Mobility; 7) Hand Function; 8) Participation; and 9) Recovery.
Measured: 3 months after the end of the treatment.
Zung Self-Rating Depression Scale
The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and in the middle of the treatment.
Measured: Pre-treatment
Zung Self-Rating Depression Scale
The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and in the middle of the treatment.
Measured: 4 weeks after starting the intervention (middle of the protocol)
Zung Self-Rating Depression Scale
The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and after the treatment.
Measured: after the intervention (8 weeks after starting the protocol)
Zung Self-Rating Depression Scale
The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected right after of the treatment and 3 months after the end of the treatment.
Measured: 3 months after the end of the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 20221 Feb 2024

First posted5 Apr 2022
Study start20 Apr 2022
Primary completion1 Feb 2024
Study completion1 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05311384
Sponsor's protocol ID: IRB-300008977
Status last verified: Mar 2025
First submitted: 4 Mar 2022
Last updated: 7 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.
PubMed 31992061
Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
PubMed 8466415
Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.
PubMed 17039224
Pedlow K, Lennon S, Wilson C. Application of constraint-induced movement therapy in clinical practice: an online survey. Arch Phys Med Rehabil. 2014 Feb;95(2):276-82. doi: 10.1016/j.apmr.2013.08.240. Epub 2013 Sep 8.
PubMed 24025659
Viana R, Teasell R. Barriers to the implementation of constraint-induced movement therapy into practice. Top Stroke Rehabil. 2012 Mar-Apr;19(2):104-14. doi: 10.1310/tsr1902-104.
PubMed 22436358
Fleet A, Che M, Mackay-Lyons M, Mackenzie D, Page S, Eskes G, McDonald A, Boyce J, Boe S. Examining the use of constraint-induced movement therapy in canadian neurological occupational and physical therapy. Physiother Can. 2014 Winter;66(1):60-71. doi: 10.3138/ptc.2012-61.
PubMed 24719511
Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
PubMed 17030751
Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
PubMed 11387578
Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131.
PubMed 10512918
ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. doi: 10.1001/archpsyc.1965.01720310065008. No abstract available.
PubMed 14221692
Toomey M, Nicholson D, Carswell A. The clinical utility of the Canadian Occupational Performance Measure. Can J Occup Ther. 1995 Dec;62(5):242-9. doi: 10.1177/000841749506200503.
PubMed 10152880
Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.
PubMed 18077218
Morris DM, Taub E, Macrina DM, Cook EW, Geiger BF. A method for standardizing procedures in rehabilitation: use in the extremity constraint induced therapy evaluation multisite randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):663-8. doi: 10.1016/j.apmr.2008.09.576.
PubMed 19345784
Andrabi M, Taub E, Mckay Bishop S, Morris D, Uswatte G. Acceptability of constraint induced movement therapy: influence of perceived difficulty and expected treatment outcome. Top Stroke Rehabil. 2022 Oct;29(7):507-515. doi: 10.1080/10749357.2021.1956046. Epub 2021 Aug 23.
PubMed 34425065
Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
PubMed 17039223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity Recovery Following Stroke: A Pilot Study
ClinicalTrials.gov ID: NCT05311384
Acronym / sponsor ID: IRB-300008977
Conditions: CVA (Cerebrovascular Accident), Stroke, Upper Extremity Paresis
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: 20 Apr 2022 (actual)
Primary completion: 1 Feb 2024 (actual)
Study completion: 1 Feb 2024 (actual)
First posted: 5 Apr 2022 (actual)
Results: Posted 7 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Keys intervention	Experimental	Behavioral: Keys Constraint-induced Movement Therapy protocolAll participants will receive the Keys CI Therapy protocol over an 8-week intervention period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 6 months after stroke
Ability to demonstrate minimum movement criteria of more-affected UE including 10 degrees of wrist extension (starting from a fully flexed position), 10 degrees of thumb abduction, and 10 degrees of extension of two additional fingers at all joints
Score <2.5 on the MAL indicating significant functional deficits of the more-affected UE

Key exclusion criteria (3 listed)

Inability to answer the MAL questions and/or provide informed consent
Score <24 on the Mini-Mental State Examination
No availability to come to the clinic for the sessions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Keys Constraint-induced Movement Therapy protocolAll participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.	Behavioural	Keys intervention

Primary outcome

Motor Activity Log (MAL)
Time frame: Pre-treatment
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Motor Activity Log (MAL)
Time frame: 4 weeks after starting the intervention (middle of the protocol)
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Motor Activity Log (MAL)
Time frame: after the intervention (8 weeks after starting the protocol)
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment.The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity before and after the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.
Motor Activity Log (MAL)
Time frame: 3 months after the end of the treatment.
The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The MAL includes two scales: Amount of use (AOU) and Quality of Movement (QOM) and each one of them is scored from 0-10, and higher scores denote more frequent spontaneous use and better quality of movement of the affected arm.
Canadian Occupational Performance Measure (COPM)
Time frame: Pre-treatment
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Canadian Occupational Performance Measure (COPM)
Time frame: 4 weeks after starting the intervention (middle of the protocol)
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Canadian Occupational Performance Measure (COPM)
Time frame: after the intervention (8 weeks after starting the protocol)
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Canadian Occupational Performance Measure (COPM)
Time frame: 3 months after the end of the treatment.
The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before, in the middle of the treatment and after the treatment. Five of the activities considered more important to the individuals are scored through two different scales: the performance and the satisfaction scales. Each one is scored from 0-10, and higher scores denote higher satisfaction, and quality of performance.
Wolf Motor Function Test (WMFT) - Performance Time
Time frame: Pre-treatment
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Wolf Motor Function Test (WMFT) - Performance Time
Time frame: 4 weeks after starting the intervention (middle of the protocol)
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Wolf Motor Function Test (WMFT) - Performance Time
Time frame: after the intervention (8 weeks after starting the protocol)
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Wolf Motor Function Test (WMFT) - Functional Ability Scale
Time frame: Pre-treatment
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Wolf Motor Function Test (WMFT) - Functional Ability Scale
Time frame: 4 weeks after starting the intervention (middle of the protocol)
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.
Wolf Motor Function Test (WMFT) - Functional Ability Scale
Time frame: after the intervention (8 weeks after starting the protocol)
The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The WMFT is scored in two different ways: through performance times (in seconds) and quality of performance through the Functional Ability Scale (FAS). The FAS ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.

8 secondary outcomes

Stroke Impact Scale (SIS)
Time frame: Pre-treatment
Stroke Impact Scale (SIS)
Time frame: 4 weeks after starting the intervention (middle of the protocol)
Stroke Impact Scale (SIS)
Time frame: after the intervention (8 weeks after starting the protocol)
Stroke Impact Scale (SIS)
Time frame: 3 months after the end of the treatment.
Zung Self-Rating Depression Scale
Time frame: Pre-treatment
Zung Self-Rating Depression Scale
Time frame: 4 weeks after starting the intervention (middle of the protocol)
Zung Self-Rating Depression Scale
Time frame: after the intervention (8 weeks after starting the protocol)
Zung Self-Rating Depression Scale
Time frame: 3 months after the end of the treatment.

Results and safety

Results posted to the registry on 7 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Keys Intervention	10	7

Primary outcome: Motor Activity Log (MAL)

Time frame: Pre-treatment. Mean (Full Range). Unit: Points

Measure	Keys Intervention n = 7
Amount of Use (AOU) Scale	1 (0.3 to 1.6)
Quality of Movement (QOM)	1.1 (0.3 to 1.5)

Primary outcome: Motor Activity Log (MAL)

Time frame: 4 weeks after starting the intervention (middle of the protocol). Mean (Full Range). Unit: Points

Measure	Keys Intervention n = 7
Amount of Use (AOU) Scale	3.5 (1.9 to 4.5)
Quality of Movement (QOM)	3.3 (2.0 to 4.4)

Primary outcome: Motor Activity Log (MAL)

Time frame: after the intervention (8 weeks after starting the protocol). Mean (Full Range). Unit: Points

Measure	Keys Intervention n = 7
Amount of Use (AOU)	3.9 (2.5 to 4.8)
Quality of Movement (QOM)	3.4 (1.7 to 4.7)

Primary outcome: Motor Activity Log (MAL)

Time frame: 3 months after the end of the treatment.. Mean (Full Range). Unit: Points

Measure	Keys Intervention n = 7
Amount of Use (AOU)	4.0 (2.8 to 4.8)
Quality of Movement	3.7 (2.1 to 4.8)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events information were monitored and collected throughout the eight weeks of intervention. All participants were asked about soreness and fatigue at the beginning of each treatment session.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Keys Intervention	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): This study has a small sample size due to challenges in recruitment and enrollment. The recruitment process was somewhat impacted by the COVID-19 pandemic due to transportation limitations, and difficulties in controlling health conditions (e.g., arterial hypertension). While the results of this pilot trial are promising, larger studies with comparison groups are needed. Additionally, the use of wearable sensors that could provided data comparable to the MAL scores would be indicated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31992061Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.
Background: PubMed 8466415Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
Background: PubMed 17039224Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.
Background: PubMed 24025659Pedlow K, Lennon S, Wilson C. Application of constraint-induced movement therapy in clinical practice: an online survey. Arch Phys Med Rehabil. 2014 Feb;95(2):276-82. doi: 10.1016/j.apmr.2013.08.240. Epub 2013 Sep 8.
Background: PubMed 22436358Viana R, Teasell R. Barriers to the implementation of constraint-induced movement therapy into practice. Top Stroke Rehabil. 2012 Mar-Apr;19(2):104-14. doi: 10.1310/tsr1902-104.
Background: PubMed 24719511Fleet A, Che M, Mackay-Lyons M, Mackenzie D, Page S, Eskes G, McDonald A, Boyce J, Boe S. Examining the use of constraint-induced movement therapy in canadian neurological occupational and physical therapy. Physiother Can. 2014 Winter;66(1):60-71. doi: 10.3138/ptc.2012-61.
Background: PubMed 17030751Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
Background: PubMed 11387578Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
Background: PubMed 10512918Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131.
Background: PubMed 14221692ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. doi: 10.1001/archpsyc.1965.01720310065008. No abstract available.
Background: PubMed 10152880Toomey M, Nicholson D, Carswell A. The clinical utility of the Canadian Occupational Performance Measure. Can J Occup Ther. 1995 Dec;62(5):242-9. doi: 10.1177/000841749506200503.
Background: PubMed 18077218Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Keys Constraint-induced Movement Therapy protocol in people with CVA (Cerebrovascular Accident) and Stroke, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Activity Log (MAL) (time frame: Pre-treatment). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05311384, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.