HemiparesisNCT06457022
Outcome Measures of Modified Constraint Induced Movement Therapy Versus Dual Task Training on Upper Extremity and Cognitive Functions in Patients With Hemiparesis
A study testing Modified Constraint Induced Movement therapy, Dual task training in the form of cognitive - motor task and Conventional physiotherapy rehabilitation program in people with Hemiparesis, run by Ahmed Alshimy at 1 site in Egypt.
Trial summary
All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Modified Constraint Induced Movement therapy, Dual task training in the form of cognitive - motor task and Conventional physiotherapy rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age range between 55 and 65 years old.
- The patients were from both genders (males \&females).
- Patients were of duration of illness between 6 and 12 months.
- The patients were scoring 1 \&1+ on modified Ashworth scale (mild spasticity).
- The patients were of good ability to see and hear.
- Consent form was obtained from all participants to approve the study and follow the commands.
- All patients were scoring more than 26 on MMSE. All patients were medically stable.
Who cannot join
- patients with moderate and sever spasticity.
- patients with cognitive disorder due to other cause rather than spasticity.
- patients with unstable medical conditions.
- patients with previous or recurrent stroke.
- patients with respiratory problems.
- patients with shoulder dislocation or subluxation or frozen shoulder.
- patients with uncontrolled hypertension, diabetes mellitus, unstable angina or heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.
Read the detailed description
The patients were classified randomly into three equal groups, Study group A (GA) receiving modified constraint induced movement therapy in addition to conventional physical therapy program, Study group B (GB) receiving dual task training in addition to conventional physical therapy program and control group C (GC) receiving only conventional physiotherapy program.
- Conditions
- Hemiparesis
- Being tested
- Modified Constraint Induced Movement therapy, Dual task training in the form of cognitive - motor task, Conventional physiotherapy rehabilitation program
- Keywords
- Modified constraint induced movement therapy, Hemiparesis, Dual task training, Upper extremity, Cognitive functions
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint Induced Movement therapyOther
patient wears a restraint instrument in his unaffected hand, then applying massed practice to his affected upper extremity. The patient wears padded glove in his unaffected upper extremity for restraining the patient from using his unaffected upper extremity for about 3 hours per day including the treatment session and the home program. So, by this way the patient is reinforced to use his affected upper extremity during this period of time to achieve his activities of daily living. Finally, the total time, the patient spends it during the day wearing the glove should be recorded each day.
Dual task training in the form of cognitive - motor taskOther
Verbal fluency: Ask the hemiparetic patient to title many words of specific type as fruits, vegetable or animals. Mental tracking: as the hemiparetic patient to subtract serial 3 between number 90 and 100.
Conventional physiotherapy rehabilitation programOther
Ultrasound on shoulder. Graduated active exercises for shoulder. Prolonged stretching for spastic muscles
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Receiving modified constraint induced movement therapy , for 30 minutes , in addition to conventional physiotherapy program for the other 30 minutes. Receives: Other: Modified Constraint Induced Movement therapy; Other: Conventional physiotherapy rehabilitation program |
| Group B | Experimental | Receiving dual task training (Cognitive-Motor) for 30 minutes, in addition to conventional physiotherapy program for the other 30 minutes. Receives: Other: Dual task training in the form of cognitive - motor task; Other: Conventional physiotherapy rehabilitation program |
| Group C | Other | Receiving only conventional physiotherapy program for 60 minutes. Receives: Other: Conventional physiotherapy rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex isokinetic dynamometer
Used to assess muscle strength and function
Measured: 4 weeks
Montreal cognitive assessment
a quick test that is used to examine mild cognitive impairment and early dementia.
Measured: 4 weeks
Fugl Myer upper extremity
a scale used to measure the functional impairment of stroke
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start10 Jun 2024
- Primary completion5 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Alshimy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Alshimy, AlRyada University for Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457022
- Sponsor's protocol ID
- P.T.REC/012/005007
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Measures of Modified Constraint Induced Movement Therapy Versus Dual Task Training on Upper Extremity and Cognitive Functions in Patients With Hemiparesis
- ClinicalTrials.gov ID
- NCT06457022
- Acronym / sponsor ID
- P.T.REC/012/005007
- Conditions
- Hemiparesis
- Keywords
- Modified constraint induced movement therapy, Hemiparesis, Dual task training, Upper extremity, Cognitive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ahmed AlshimyUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.
Detailed description
The patients were classified randomly into three equal groups, Study group A (GA) receiving modified constraint induced movement therapy in addition to conventional physical therapy program, Study group B (GB) receiving dual task training in addition to conventional physical therapy program and control group C (GC) receiving only conventional physiotherapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Modified Constraint Induced Movement therapy, Other: Conventional physiotherapy rehabilitation programReceiving modified constraint induced movement therapy , for 30 minutes , in addition to conventional physiotherapy program for the other 30 minutes. |
| Group B | Experimental | Other: Dual task training in the form of cognitive - motor task, Other: Conventional physiotherapy rehabilitation programReceiving dual task training (Cognitive-Motor) for 30 minutes, in addition to conventional physiotherapy program for the other 30 minutes. |
| Group C | Other | Other: Conventional physiotherapy rehabilitation programReceiving only conventional physiotherapy program for 60 minutes. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with age range between 55 and 65 years old.
- The patients were from both genders (males \&females).
- Patients were of duration of illness between 6 and 12 months.
- The patients were scoring 1 \&1+ on modified Ashworth scale (mild spasticity).
- The patients were of good ability to see and hear.
Key exclusion criteria (7 listed)
- patients with moderate and sever spasticity.
- patients with cognitive disorder due to other cause rather than spasticity.
- patients with unstable medical conditions.
- patients with previous or recurrent stroke.
- patients with respiratory problems.
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 |
|---|---|---|
| Modified Constraint Induced Movement therapypatient wears a restraint instrument in his unaffected hand, then applying massed practice to his affected upper extremity. The patient wears padded glove in his unaffected upper extremity for restraining the patient from using his unaffected upper extremity for about 3 hours per day including the treatment session and the home program. So, by this way the patient is reinforced to use his affected upper extremity during this period of time to achieve his activities of daily living. Finally, the total time, the patient spends it during the day wearing the glove should be recorded each day. | Other | Group A |
| Dual task training in the form of cognitive - motor taskVerbal fluency: Ask the hemiparetic patient to title many words of specific type as fruits, vegetable or animals. Mental tracking: as the hemiparetic patient to subtract serial 3 between number 90 and 100. | Other | Group B |
| Conventional physiotherapy rehabilitation programUltrasound on shoulder. Graduated active exercises for shoulder. Prolonged stretching for spastic muscles | Other | Group A, Group B, Group C |
Primary outcome
Biodex isokinetic dynamometer
Time frame: 4 weeks
Used to assess muscle strength and function
Montreal cognitive assessment
Time frame: 4 weeks
a quick test that is used to examine mild cognitive impairment and early dementia.
Fugl Myer upper extremity
Time frame: 4 weeks
a scale used to measure the functional impairment of stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
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Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
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Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
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 Modified Constraint Induced Movement therapy, Dual task training in the form of cognitive - motor task and Conventional physiotherapy rehabilitation program in people with Hemiparesis, run by Ahmed Alshimy at 1 site in Egypt.
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 7 inclusion and 7 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 19 Jul 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biodex isokinetic dynamometer (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2024.