StrokeNCT01157195
Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
A study testing Tele-AutoCITE and CI therapy in people with Stroke, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical rehabilitation derived from basic behavioral and neuroscience research. It has been shown to be efficacious for rehabilitating use of the more-affected arm in individuals more than one year after stroke with mild to moderate… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tele-AutoCITE and CI therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 1 year after stroke
- some ability to voluntarily open fingers on more affected side of body
- some ability to voluntarily raise wrist on more affected side of body
- ability to stand independently for two minutes
- ability to transfer from sit to stand independently
Who cannot join
- serious, concurrent medical conditions including frailty
- excessive spasticity (high muscle tone) in more affected arm
- impairment in thinking that makes compliance with study activities difficult
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical rehabilitation derived from basic behavioral and neuroscience research. It has been shown to be efficacious for rehabilitating use of the more-affected arm in individuals more than one year after stroke with mild to moderate motor impairment. The first component of the therapy is intensive training in use of the more-affected arm on functional tasks for 3 hours daily for 10 consecutive weekdays. The second is wearing a protective safety mitt on the less-affected hand for all waking hours of the approximately 2-week treatment period that it is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The third is a group of behavioral techniques designed to transfer gains from the treatment setting to the real world, which takes a therapist, on average, 30 minutes to implement on each treatment day.
The purpose of this project is to develop and test a method for automating the delivery of this efficacious treatment in a way that the therapy can be provided in stroke patients' homes. After developing an automated CI therapy workstation that has tele-health capabilities, the investigators will conduct a randomized controlled trial to evaluate whether CI therapy delivered in the home using this workstation with remote supervision by a therapist via an Internet-based audiovisual link provides outcomes that are just as good as CI therapy delivered by a "live" therapist.
- Conditions
- Stroke
- Being tested
- Tele-AutoCITE, CI therapy
- Keywords
- stroke, chronic, arm, rehabilitation, tele-health
- Medical subject headings
- Stroke, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-AutoCITEBehavioural
Automated, remotely-administered form of CI therapy
CI therapyBehavioural
CI therapy is a behavioral approach to physical rehabilitation that has three components: 1. intense training of the more affected arm for several hours daily for multiple consecutive days, 2. restraint of the less affected arm during training hours and afterwards during the treatment period, 3. A package of behavioral techniques designed to transfer gains from the treatment setting to daily life. In this trial, CI therapy will be administered for 3 1/2 hours per day for 10 consecutive weekdays.
| Study group | Role | What they receive |
|---|---|---|
| CI therapy | Active comparator | Not described Receives: Behavioral: CI therapy |
| Tele-AutoCITE | Experimental | AutoCITE stands for Automated Constraint Induced Therapy Extender. Receives: Behavioral: Tele-AutoCITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks
Well-validated structured interview that assesses how much and how well the more-affected arm after stroke has been used to accomplish everyday activities over a specified period.
Measured: Baseline to 2 weeks (average)
Secondary outcomes (3)
Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks
Well-validated laboratory motor performance test that assesses how quickly an individual can perform upper-extremity tasks with the more-affected arm after stroke.
Measured: Baseline to 2 weeks (average)
Change in MAL Arm Use Scale at 6 months
See primary outcome.
Measured: Baseline to 6 months (average)
Change in MAL Arm Use Scale at 12 months
See primary outcome.
Measured: Baseline to 12 months (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2013
- Study completionAug 2018
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 StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Gitendra Uswatte, University of Alabama at Birmingham
- Investigators
- Gitendra Uswatte, PhD, Principal investigator, Psychology Department, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157195
- Sponsor's protocol ID
- F071227003
- Other IDs
- R01HD053750
- Status last verified
- Sep 2018
- First submitted
- 17 Jun 2010
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taub E, Uswatte G, Pidikiti R. Constraint-Induced Movement Therapy: a new family of techniques with broad application to physical rehabilitation--a clinical review. J Rehabil Res Dev. 1999 Jul;36(3):237-51.
PubMed 10659807
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
- ClinicalTrials.gov ID
- NCT01157195
- Acronym / sponsor ID
- F071227003
- Conditions
- Stroke
- Keywords
- stroke, chronic, arm, rehabilitation, tele-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Jul 2010 (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.
Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical rehabilitation derived from basic behavioral and neuroscience research. It has been shown to be efficacious for rehabilitating use of the more-affected arm in individuals more than one year after stroke with mild to moderate motor impairment. The first component of the therapy is intensive training in use of the more-affected arm on functional tasks for 3 hours daily for 10 consecutive weekdays. The second is wearing a protective safety mitt on the less-affected hand for all waking hours of the approximately 2-week treatment period that it is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The third is a group of behavioral techniques designed to transfer gains from the treatment setting to the real world, which takes a therapist, on average, 30 minutes to implement on each treatment day.
The purpose of this project is to develop and test a method for automating the delivery of this efficacious treatment in a way that the therapy can be provided in stroke patients' homes. After developing an automated CI therapy workstation that has tele-health capabilities, the investigators will conduct a randomized controlled trial to evaluate whether CI therapy delivered in the home using this workstation with remote supervision by a therapist via an Internet-based audiovisual link provides outcomes that are just as good as CI therapy delivered by a "live" therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CI therapy | Active comparator | Behavioral: CI therapy |
| Tele-AutoCITE | Experimental | Behavioral: Tele-AutoCITEAutoCITE stands for Automated Constraint Induced Therapy Extender. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- more than 1 year after stroke
- some ability to voluntarily open fingers on more affected side of body
- some ability to voluntarily raise wrist on more affected side of body
- ability to stand independently for two minutes
- ability to transfer from sit to stand independently
Key exclusion criteria (3 listed)
- serious, concurrent medical conditions including frailty
- excessive spasticity (high muscle tone) in more affected arm
- impairment in thinking that makes compliance with study activities difficult
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 |
|---|---|---|
| Tele-AutoCITEAutomated, remotely-administered form of CI therapy | Behavioural | Tele-AutoCITE |
| CI therapyCI therapy is a behavioral approach to physical rehabilitation that has three components: 1. intense training of the more affected arm for several hours daily for multiple consecutive days, 2. restraint of the less affected arm during training hours and afterwards during the treatment period, 3. A package of behavioral techniques designed to transfer gains from the treatment setting to daily life. In this trial, CI therapy will be administered for 3 1/2 hours per day for 10 consecutive weekdays. | Behavioural | CI therapy |
Primary outcome
Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks
Time frame: Baseline to 2 weeks (average)
Well-validated structured interview that assesses how much and how well the more-affected arm after stroke has been used to accomplish everyday activities over a specified period.
3 secondary outcomes
Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks
Time frame: Baseline to 2 weeks (average)
Change in MAL Arm Use Scale at 6 months
Time frame: Baseline to 6 months (average)
Change in MAL Arm Use Scale at 12 months
Time frame: Baseline to 12 months (average)
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 28 Sep 2018.
- Background: PubMed 10659807Taub E, Uswatte G, Pidikiti R. Constraint-Induced Movement Therapy: a new family of techniques with broad application to physical rehabilitation--a clinical review. J Rehabil Res Dev. 1999 Jul;36(3):237-51.
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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.
Gitendra Uswatte, PhD principal investigator
Psychology Department, 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 study testing Tele-AutoCITE and CI therapy in people with 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 5 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 28 Sep 2018. 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?
Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks (time frame: Baseline to 2 weeks (average)). 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 NCT01157195, 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 28 Sep 2018.