Systemic SclerosisREACHNCT03482219
Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis
A study testing Occupational therapy and Home app intervention in people with Systemic Sclerosis and SSc, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to test two rehabilitation programs to improve arm function for patients with scleroderma. This is a Phase 2 randomized controlled trial in which participants will be assessed at baseline, 8 weeks, and 18 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, SSc
- What is being tested?
- Occupational therapy and Home app intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 26 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of systemic sclerosis including:
- Diffuse cutaneous subset
- Disease duration < 5 years from 1st non Raynaud phenomenon sign or symptom
- Have a contracture of the hand and other joint in at least one arm, such as wrist, elbow, or shoulder, with the ability to demonstrate active range of motion in that arm
- Willing to travel to participate in therapy and outcome assessments.
- Have an Android, iPhone, iPad or computer tablet to load the home exercise App.
- English speaking
Who cannot join
- issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to use home exercise app, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis (The REACH Study)
The purpose of this study is to test two rehabilitation programs to improve arm function for patients with scleroderma. This is a Phase 2 randomized controlled trial in which participants will be assessed at baseline, 8 weeks, and 18 weeks. Participants will be randomized into an intensive intervention (8 individual sessions of occupational therapy plus a home exercise app) versus a home app treatment alone. The results of this study will be used to design a large multi-site trial in which optimized rehabilitation strategies can be used to help patients improve their arm function.
Read the detailed description
The specific aims of this study are to:
- Determine the short and longer-term effects of an intensive (8-week in-person occupational therapy treatment with prescribed home exercises) on improving arm function versus home exercise alone. This study's hypothesis is that immediately following treatment at 8 weeks and at 18 weeks, participants randomized to the in-person occupational therapy will have significant improvements in the QuickDASH disability measure, PROMIS physical function measure, and total active hand function compared to the home exercise alone.
- Determine how adherence to home exercise in both groups influences treatment effects.
This study's hypothesis is that adherence will independently predict improvement in outcomes at 8 and 18 weeks regardless of treatment group assignment and that higher adherence to the home exercise program will result in greater and more long-lasting improvements.
- Conditions
- Systemic Sclerosis, SSc
- Being tested
- Occupational therapy, Home app intervention
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapyOther
The Occupational therapy intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education. The home app intervention involves one session of education with the occupational therapist.
Home app interventionOther
The app consists of videos depicting each exercise and ability to track adherence to exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment | Experimental | Participants will undergo 8 sessions with an occupational therapist. Participants will meet with the occupational therapist to establish the home exercise program and set up the home exercise app. The app has videos depicting each exercise and ability to track adherence to exercises. The occupational therapy consists of the following which will be provided as appropriate:
1. Thermal Modalities Hot packs, focused on areas with limitations Paraffin, focused on digital limitations
2. Application of the Physiotouch (a low-intensity negative pressure device)
3. Passive Range of Motion
4. Active Range of Motion
5. Functional Activities Receives: Other: Occupational therapy; Other: Home app intervention |
| Home app intervention | Active comparator | Participants will meet with the occupational therapist to establish the home exercise program and set up the home exercise app. The app has videos depicting each exercise and ability to track adherence to exercises. Receives: Other: Home app intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
quickDASH
self-report questionnaire of physical function and symptoms. This is an 11-item questionnaire in which difficulty in several tasks involving the upper extremity are rated as well as interference and severity of symptoms. Items are averaged and converted to a 0 - 100 scale; a higher score indicates worse function.
Measured: Change from Baseline at 8 weeks and 18 weeks
Secondary outcomes (2)
Physical Function
PROMIS physical function 8-item short form. The US population mean score for this measure is 50 with SD of 10, and a higher score denotes better function
Measured: Change from Baseline at 8 weeks and 18 weeks
Total Hand Function
Summary score of degrees of active range of motion in hand. This is calculated by summing the total active range of motion for each finger and thumb by goniometer (260 degrees in each finger and 135 in the thumb). A total score of 1125 is possible and a higher score equals more range of motion
Measured: Change from Baseline at 8 weeks and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start16 Apr 2018
- Primary completion15 May 2020
- Study completion26 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Scleroderma Foundation
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan Murphy, ScD OTR, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482219
- Sponsor's protocol ID
- HUM00141111
- Acronym
- REACH
- Status last verified
- Sep 2020
- First submitted
- 22 Mar 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy SL, Barber M, Huang S, Sabbagh M, Cutter G, Khanna D. Intensive and app-delivered occupational therapy to improve upper extremity function in early diffuse cutaneous systemic sclerosis: a pilot two-arm trial. Rheumatology (Oxford). 2021 Nov 3;60(11):5002-5011. doi: 10.1093/rheumatology/keab339.
PubMed 33839775
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis (The REACH Study)
- ClinicalTrials.gov ID
- NCT03482219
- Acronym / sponsor ID
- REACH / HUM00141111
- Conditions
- Systemic Sclerosis, SSc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Scleroderma Foundation
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 26 Sep 2020 (actual)
- First posted
- 29 Mar 2018 (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.
The purpose of this study is to test two rehabilitation programs to improve arm function for patients with scleroderma. This is a Phase 2 randomized controlled trial in which participants will be assessed at baseline, 8 weeks, and 18 weeks. Participants will be randomized into an intensive intervention (8 individual sessions of occupational therapy plus a home exercise app) versus a home app treatment alone. The results of this study will be used to design a large multi-site trial in which optimized rehabilitation strategies can be used to help patients improve their arm function.
Detailed description
The specific aims of this study are to:
- Determine the short and longer-term effects of an intensive (8-week in-person occupational therapy treatment with prescribed home exercises) on improving arm function versus home exercise alone. This study's hypothesis is that immediately following treatment at 8 weeks and at 18 weeks, participants randomized to the in-person occupational therapy will have significant improvements in the QuickDASH disability measure, PROMIS physical function measure, and total active hand function compared to the home exercise alone.
- Determine how adherence to home exercise in both groups influences treatment effects.
This study's hypothesis is that adherence will independently predict improvement in outcomes at 8 and 18 weeks regardless of treatment group assignment and that higher adherence to the home exercise program will result in greater and more long-lasting improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment | Experimental | Other: Occupational therapy, Other: Home app interventionParticipants will undergo 8 sessions with an occupational therapist. Participants will meet with the occupational therapist to establish the home exercise program and set up the home exercise app. The app has videos depicting each exercise and ability to track adherence to exercises. The occupational therapy consists of the following which will be provided as appropriate: 1. Thermal Modalities Hot packs, focused on areas with limitations Paraffin, focused on digital limitations 2. Application of the Physiotouch (a low-intensity negative pressure device) 3. Passive Range of Motion 4. Active Range of Motion 5. Functional Activities |
| Home app intervention | Active comparator | Other: Home app interventionParticipants will meet with the occupational therapist to establish the home exercise program and set up the home exercise app. The app has videos depicting each exercise and ability to track adherence to exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a diagnosis of systemic sclerosis including:
- Have a contracture of the hand and other joint in at least one arm, such as wrist, elbow, or shoulder, with the ability to demonstrate active range of motion in that arm
- Willing to travel to participate in therapy and outcome assessments.
- Have an Android, iPhone, iPad or computer tablet to load the home exercise App.
- English speaking
Key exclusion criteria (1 listed)
- issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to use home exercise app, etc.)
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 |
|---|---|---|
| Occupational therapyThe Occupational therapy intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education. The home app intervention involves one session of education with the occupational therapist. | Other | Intensive treatment |
| Home app interventionThe app consists of videos depicting each exercise and ability to track adherence to exercises. | Other | Home app intervention, Intensive treatment |
Primary outcome
quickDASH
Time frame: Change from Baseline at 8 weeks and 18 weeks
self-report questionnaire of physical function and symptoms. This is an 11-item questionnaire in which difficulty in several tasks involving the upper extremity are rated as well as interference and severity of symptoms. Items are averaged and converted to a 0 - 100 scale; a higher score indicates worse function.
2 secondary outcomes
Physical Function
Time frame: Change from Baseline at 8 weeks and 18 weeks
Total Hand Function
Time frame: Change from Baseline at 8 weeks and 18 weeks
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 29 Sep 2020.
- Derived from this study: PubMed 33839775Murphy SL, Barber M, Huang S, Sabbagh M, Cutter G, Khanna D. Intensive and app-delivered occupational therapy to improve upper extremity function in early diffuse cutaneous systemic sclerosis: a pilot two-arm trial. Rheumatology (Oxford). 2021 Nov 3;60(11):5002-5011. doi: 10.1093/rheumatology/keab339.
- 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.
Susan Murphy, ScD OTR principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy and Home app intervention in people with Systemic Sclerosis and SSc, run by University of Michigan 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 7 inclusion and 1 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 29 Sep 2020. 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?
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?
quickDASH (time frame: Change from Baseline at 8 weeks and 18 weeks). 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 NCT03482219, which also lists 1 linked publication.
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 29 Sep 2020.