SclerodermaNCT02837549
Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
A study testing Occupational therapy treatment in people with Scleroderma and Ssc, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Ssc
- What is being tested?
- Occupational therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2017
- 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
- diagnosis of scleroderma (localized or generalized morphea)
- 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.
- English speaking
Who cannot join
- active hand ulcers
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual sessions with an occupational therapist. Feasibility of the procedures is a major focus of this project.
Read the detailed description
Our specific aims are to:
- Determine the feasibility of a novel rehabilitation strategy provided at the University of Michigan Scleroderma Clinic to scleroderma patients who have upper extremity contractures. Investigators will assess 3 main aspects of the process that are key to the success of a larger study including the proportion of eligible people who enroll in the study, rate of adherence to the treatment protocol, and the time it takes to conduct sessions including treatment and outcome assessment completion. Based on a framework of recommendations for well-designed pilot studies [1], investigators have set the following criteria for success to examine these aspects:
- At least 50% of participants who are eligible for the study will enroll.
- At least 80% of participants will attend all treatment sessions.
- The 3 sessions involving both treatment and outcome assessments will not last on average more than 2 hours.
- Develop a standardized treatment manual to train therapists to provide this treatment to their patients. A standardized treatment manual for therapists is a critical component needed to ensure consistency in a larger multi-site trial. This manual will be drafted for use in this study and refined as needed.
- Establish preliminary effects of this 8-week rehabilitation program on improving arm function.
Investigators hypothesize that participants with scleroderma will have significant improvements in the QuickDASH disability measure at post test. Although the investigators think large effects will be shown, this study will allow us to determine estimates of the effects and the variability for power calculations in a multi-site trial.
- Conditions
- Scleroderma, Ssc
- Being tested
- Occupational therapy treatment
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapy treatmentOther
Also called Upper Extremity Rehabilitation
This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education
| Study group | Role | What they receive |
|---|---|---|
| Occupational therapy treatment | Experimental | Participants will undergo the following 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 treatment |
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
Measured: change over 8 weeks
Secondary outcomes (4)
Upper extremity range of motion
Active and Passive Range of Motion measured by goniometer
Measured: change over 8 weeks
Coordination
9 hole peg test
Measured: change over 8 weeks
Grip Strength
dynanometer
Measured: change over 8 weeks
Physical Function
PROMIS physical function 8-item short form
Measured: change over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
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 SclerodermaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan Murphy, ScD, Principal investigator, University of Michigan - Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837549
- Sponsor's protocol ID
- HUM00117117
- Status last verified
- Oct 2017
- First submitted
- 5 Jul 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: upon written request
Publications
Murphy SL, Barber MW, Homer K, Dodge C, Cutter GR, Khanna D. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1653-1660. doi: 10.1002/acr.23522.
PubMed 29381834
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
- ClinicalTrials.gov ID
- NCT02837549
- Acronym / sponsor ID
- HUM00117117
- Conditions
- Scleroderma, Ssc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Jul 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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 determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual sessions with an occupational therapist. Feasibility of the procedures is a major focus of this project.
Detailed description
Our specific aims are to:
- Determine the feasibility of a novel rehabilitation strategy provided at the University of Michigan Scleroderma Clinic to scleroderma patients who have upper extremity contractures. Investigators will assess 3 main aspects of the process that are key to the success of a larger study including the proportion of eligible people who enroll in the study, rate of adherence to the treatment protocol, and the time it takes to conduct sessions including treatment and outcome assessment completion. Based on a framework of recommendations for well-designed pilot studies [1], investigators have set the following criteria for success to examine these aspects:
- At least 50% of participants who are eligible for the study will enroll.
- At least 80% of participants will attend all treatment sessions.
- The 3 sessions involving both treatment and outcome assessments will not last on average more than 2 hours.
- Develop a standardized treatment manual to train therapists to provide this treatment to their patients. A standardized treatment manual for therapists is a critical component needed to ensure consistency in a larger multi-site trial. This manual will be drafted for use in this study and refined as needed.
- Establish preliminary effects of this 8-week rehabilitation program on improving arm function.
Investigators hypothesize that participants with scleroderma will have significant improvements in the QuickDASH disability measure at post test. Although the investigators think large effects will be shown, this study will allow us to determine estimates of the effects and the variability for power calculations in a multi-site trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy treatment | Experimental | Other: Occupational therapy treatmentParticipants will undergo the following 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of scleroderma (localized or generalized morphea)
- 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.
- English speaking
Key exclusion criteria (1 listed)
- active hand ulcers
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 therapy treatmentAlso: Upper Extremity RehabilitationThis intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education | Other | Occupational therapy treatment |
Primary outcome
quickDASH
Time frame: change over 8 weeks
self-report questionnaire of physical function and symptoms
4 secondary outcomes
Upper extremity range of motion
Time frame: change over 8 weeks
Coordination
Time frame: change over 8 weeks
Grip Strength
Time frame: change over 8 weeks
Physical Function
Time frame: change over 8 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 26 Oct 2017.
- Derived from this study: PubMed 29381834Murphy SL, Barber MW, Homer K, Dodge C, Cutter GR, Khanna D. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1653-1660. doi: 10.1002/acr.23522.
- Individual participant dataSharing planned: Undecided. upon written request
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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 principal investigator
University of Michigan - Department of Physical Medicine and Rehabilitation
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 treatment in people with Scleroderma 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 4 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 26 Oct 2017. 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 over 8 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 NCT02837549, 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 26 Oct 2017.