Chronic Stroke Survivors With Plegic HandPhase 1/2NCT00366210
Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors w/Plegic Hands
A Phase 1/2 study testing Constraint-Induced Movement (CI) Therapy and Stretching, Relaxation, & Biofeedback in people with Chronic Stroke Survivors With Plegic Hand, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to compare modified CI therapy for strokes survivors with very limited function to an alternative package of conventional physical rehabilitation techniques Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Stroke Survivors With Plegic Hand
- What is being tested?
- Constraint-Induced Movement (CI) Therapy and Stretching, Relaxation, & Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Sep 2009
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1a. The ability to initiate extension against gravity at the wrist or at least one digit and initiate extension and flexion at the elbow.
- 1b. No active movement required for the wrist, fingers or thumb. At least 20° active extension required at elbow.
- 2. Actively move the shoulder at least 30 degrees in flexion, abduction, or scaption 3. Score less than 4 on the Modified Ashworth Scale for all impaired joints 4. Passive range of motion criteria > or equal to 90° shoulder flexion, > or equal to 90° shoulder abduction, > or equal to 45° shoulder external rotation, < or equal to 30° short of normal elbow extension, forearm supination to at least neutral, forearm pronation 45° or more from neutral, < equal to 35° short of normal wrist extension, and < equal to 35° short of normal metacarpophalangeal extension on all the digits.
- Other Exclusion Criteria. Among the principal exclusion criteria are:
- Less than 6 months post-stroke.
- Motor problems that are not primarily unilateral.
Show all 10Show fewer
- Other neurological or musculoskeletal conditions, including excessive pain, affecting UE function.
- Insufficient stamina or serious uncontrolled medical problems.
- Serious cognitive deficits including inadequate ability to follow test instructions.
- Less than 19 years old. Grade 4 MMC for wrist, thumb, fingers; i.e., individuals who can actively extend the wrist > or equal to 10°, abduct the thumb or equal to 10°, and initiate extension of at least two additional digits will be excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The purpose of this study is to compare modified CI therapy for strokes survivors with very limited function to an alternative package of conventional physical rehabilitation techniques
Read the detailed description
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, based on behavioral neuroscience studies of deafferented monkeys, that has been shown in controlled studies to produce large improvements in real-world upper-extremity use in individuals with chronic stroke. Up till now, survivors of stroke with plegic hands have been excluded from CI therapy protocols, whether on a research or clinical basis. Such individuals are estimated to make up at least 35% of the population with chronic stroke with residual motor deficit. Furthermore, there are no other interventions for such individuals that have controlled evidence of efficacy for increasing real-world function. Thus, these stroke survivors represent a large number of healthcare consumers with limited treatment options.
We recently completed a pilot study of a modified form of CI therapy for stroke survivors with plegic hands, and obtained surprisingly positive findings. Six individuals were enrolled who had a flicker of active movement at the elbow and at the wrist or a finger and 30° of active range of motion at the shoulder. Participants received three weeks of CI therapy, combined with other modes of therapy, for six hours per day. The treatment package included tone management/movement facilitation, training of more-impaired arm use using shaping, functional task practice, restraint of the less-impaired arm in the laboratory and at home as indicated, and a package of behavioral methods for transferring gains from the laboratory to the home situation. As a group, the patients showed a large improvement in more-impaired arm use in daily life after treatment (Motor Activity Log or MAL; p's < 05, Effect Size > 1.5). Improvements in more-impaired arm motor ability, as measured by scores on a laboratory motor performance test (graded Wolf Motor Function Test; gWMFT) and standardized clinical examination (Fugl-Meyer), were also substantial (p's < .05).
Based on these initial findings, we propose a randomized, controlled clinical trial to rigorously test the efficacy of this modification of CI therapy for rehabilitating arm function in chronic stroke patients with severe upper-extremity impairment. To this end, 40 survivors of stroke with plegic hands will be randomly assigned to receive the intervention described above or a placebo control procedure of the same duration. Control participants will receive either 1) tone management, EMG biofeedback and other procedures in alternating blocks for 6 hr daily for 15 consecutive weekdays or 2) usual \& customary care. Measures of arm motor ability (gWMFT; Fugl-Meyer), arm use in daily life (MAL, accelerometry), and quality of life (Stroke Impact Scale) will be administered to all participants before and after treatment and at long-term. If the modified CI therapy participants shows larger improvements in more-impaired arm function than the control group participants, this will suggest it is an efficacious treatment and raise hopes of additional recovery for a large group of healthcare consumers with limited treatment options.
- Being tested
- Constraint-Induced Movement (CI) Therapy, Stretching, Relaxation, & Biofeedback
- Keywords
- stroke, rehabilitation, physical therapy, occupational therapy, arm
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement (CI) TherapyBehavioural
Stretching, Relaxation, & BiofeedbackBehavioural
Passive stretching of both arms, EMG biofeedback for more-impaired arm
| Study group | Role | What they receive |
|---|---|---|
| Expanded CI therapy | Experimental | 3.5 hours of training for the more-affected arm set in the laboratory for 15 consecutive weekdays Receives: Behavioral: Constraint-Induced Movement (CI) Therapy |
| Placebo Control | Placebo comparator | Stretching, movement exercises, and EMG biofeedback for the same duration as the experimental intervention. Receives: Behavioral: Stretching, Relaxation, & Biofeedback |
| Usual & Customary Care Control | No intervention | Treatments available to participants as part of their regular medical care, such as conventional physical or occupational therapy. For some participants, this would involve no treatment, since all participants were more than one year post stroke.f standard clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log
Measured: Pre-treatment, Post-treatment, followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startOct 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke Survivors With Plegic HandStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gitendra Uswatte, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366210
- Sponsor's protocol ID
- F060112013
- Status last verified
- Aug 2010
- First submitted
- 18 Aug 2006
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors w/Plegic Hands
- ClinicalTrials.gov ID
- NCT00366210
- Acronym / sponsor ID
- F060112013
- Keywords
- stroke, rehabilitation, physical therapy, occupational therapy, arm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Aug 2006 (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 compare modified CI therapy for strokes survivors with very limited function to an alternative package of conventional physical rehabilitation techniques
Detailed description
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, based on behavioral neuroscience studies of deafferented monkeys, that has been shown in controlled studies to produce large improvements in real-world upper-extremity use in individuals with chronic stroke. Up till now, survivors of stroke with plegic hands have been excluded from CI therapy protocols, whether on a research or clinical basis. Such individuals are estimated to make up at least 35% of the population with chronic stroke with residual motor deficit. Furthermore, there are no other interventions for such individuals that have controlled evidence of efficacy for increasing real-world function. Thus, these stroke survivors represent a large number of healthcare consumers with limited treatment options.
We recently completed a pilot study of a modified form of CI therapy for stroke survivors with plegic hands, and obtained surprisingly positive findings. Six individuals were enrolled who had a flicker of active movement at the elbow and at the wrist or a finger and 30° of active range of motion at the shoulder. Participants received three weeks of CI therapy, combined with other modes of therapy, for six hours per day. The treatment package included tone management/movement facilitation, training of more-impaired arm use using shaping, functional task practice, restraint of the less-impaired arm in the laboratory and at home as indicated, and a package of behavioral methods for transferring gains from the laboratory to the home situation. As a group, the patients showed a large improvement in more-impaired arm use in daily life after treatment (Motor Activity Log or MAL; p's < 05, Effect Size > 1.5). Improvements in more-impaired arm motor ability, as measured by scores on a laboratory motor performance test (graded Wolf Motor Function Test; gWMFT) and standardized clinical examination (Fugl-Meyer), were also substantial (p's < .05).
Based on these initial findings, we propose a randomized, controlled clinical trial to rigorously test the efficacy of this modification of CI therapy for rehabilitating arm function in chronic stroke patients with severe upper-extremity impairment. To this end, 40 survivors of stroke with plegic hands will be randomly assigned to receive the intervention described above or a placebo control procedure of the same duration. Control participants will receive either 1) tone management, EMG biofeedback and other procedures in alternating blocks for 6 hr daily for 15 consecutive weekdays or 2) usual \& customary care. Measures of arm motor ability (gWMFT; Fugl-Meyer), arm use in daily life (MAL, accelerometry), and quality of life (Stroke Impact Scale) will be administered to all participants before and after treatment and at long-term. If the modified CI therapy participants shows larger improvements in more-impaired arm function than the control group participants, this will suggest it is an efficacious treatment and raise hopes of additional recovery for a large group of healthcare consumers with limited treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expanded CI therapy | Experimental | Behavioral: Constraint-Induced Movement (CI) Therapy3.5 hours of training for the more-affected arm set in the laboratory for 15 consecutive weekdays |
| Placebo Control | Placebo comparator | Behavioral: Stretching, Relaxation, & BiofeedbackStretching, movement exercises, and EMG biofeedback for the same duration as the experimental intervention. |
| Usual & Customary Care Control | No intervention | –Treatments available to participants as part of their regular medical care, such as conventional physical or occupational therapy. For some participants, this would involve no treatment, since all participants were more than one year post stroke.f standard clinical care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1a. The ability to initiate extension against gravity at the wrist or at least one digit and initiate extension and flexion at the elbow.
- 1b. No active movement required for the wrist, fingers or thumb. At least 20° active extension required at elbow.
- 2. Actively move the shoulder at least 30 degrees in flexion, abduction, or scaption 3. Score less than 4 on the Modified Ashworth Scale for all impaired joints 4. Passive range of motion criteria > or equal to 90° shoulder flexion, > or equal to 90° shoulder abduction, > or equal to 45° shoulder external rotation, < or equal to 30° short of normal elbow extension, forearm supination to at least neutral, forearm pronation 45° or more from neutral, < equal to 35° short of normal wrist extension, and < equal to 35° short of normal metacarpophalangeal extension on all the digits.
- Less than 6 months post-stroke.
- Motor problems that are not primarily unilateral.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Constraint-Induced Movement (CI) Therapy | Behavioural | Expanded CI therapy |
| Stretching, Relaxation, & BiofeedbackPassive stretching of both arms, EMG biofeedback for more-impaired arm | Behavioural | Placebo Control |
Primary outcome
Motor Activity Log
Time frame: Pre-treatment, Post-treatment, followup
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 25 Dec 2014.
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.
Gitendra Uswatte, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Constraint-Induced Movement (CI) Therapy and Stretching, Relaxation, & Biofeedback in people with Chronic Stroke Survivors With Plegic Hand, 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 10 inclusion and 0 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 25 Dec 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Motor Activity Log (time frame: Pre-treatment, Post-treatment, followup). 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 25 Dec 2014.