StrokeNCT02247674
Bilateral Movement Training for People With Stroke
A study testing Bilateral movement training in people with Stroke and Cerebrovascular Accident, run by Chueh-Ho Lin at 1 site in Taiwan.
Trial summary
The investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. In order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional… Read more about this study
- Who is it for?
- Ages 28 to 81 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Cardiovascular Disease
- What is being tested?
- Bilateral movement training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2012to Oct 2013
- 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 28 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 6 months since stroke
- three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
- ability to flex and extend the paretic arm and hand
- Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
- Mini-Mental State Examination (MMSE) score should 24 or higher
- no other orthopedic neurological disorders
- Brunnstrom stage 3 or 4
- no joint in other experimental rehabilitation or drug studies 21
Who cannot join
- unstable cardiovascular conditions
- uncontrolled hypertension (190/110 mm Hg)
- severe orthopedic or pain conditions
- dementia (Mini-Mental State Examination score < 22)
- aphasia with inability to follow researcher's commands
- severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Computer-aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control Following Chronic Stroke
The investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. In order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional performances, the investigators also hypothesized that motor recovery and functional performances improvements of paretic arm and hand have strongly correlation.
Read the detailed description
Objective: To investigate the training effects of interlimb force coupling training on paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the relationship between motor recovery of paretic hand, arm and functional abilities.
Design: A double-blind randomized controlled trial with outcome assessment at baseline and after 4 weeks intervention.
Setting: Department of physical medicine and rehabilitation in Taipei Veterans General Hospital.
Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were recruited and randomized assigned to training (n=16) and control group (n=17).
Interventions: Interlimb force coupling training task included different gripforce generation on the both hands.
Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function Test (WMFT). All assessment was executed by a blinded evaluator, and data management and statistical analysis was also conducted by a blinded statistic researcher.
- Conditions
- Stroke, Cerebrovascular Accident, Cardiovascular Disease, Brain Injury
- Being tested
- Bilateral movement training
- Keywords
- Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity
- Medical subject headings
- Stroke, Cardiovascular Diseases, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral movement trainingProcedure or surgery
Also called Coupling movement
Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Education & training consultation | Placebo comparator | Education and training consultations were provided for subjects in control group during study period. Receives: Procedure: Bilateral movement training |
| Bilateral movement training | Experimental | Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions) Receives: Procedure: Bilateral movement training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
Outcome measure was assessed before and after 4 weeks intervention.
Measured: before and after 4 weeks intervention
Secondary outcomes (3)
Barthel Index (BI)
Outcome measure was assessed before and after 4 weeks intervention.
Measured: before and after 4 weeks intervention
Motor Assessment Score (MAS)
Outcome measure was assessed before and after 4 weeks intervention.
Measured: before and after 4 weeks intervention
Wolf Motor Function Test (WMFT)
Outcome measure was assessed before and after 4 weeks intervention.
Measured: before and after 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionOct 2013
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chueh-Ho Lin
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor-investigator, Chueh-Ho Lin, National Yang Ming Chiao Tung University
- Investigators
- Wen-Hsu Sung, PhD, Study chair, Department of Physical Therapy and Assistive Technology, National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247674
- Sponsor's protocol ID
- NYMU20140829
- Status last verified
- Sep 2014
- First submitted
- 31 Aug 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, Sung WH. Effects of Computer-Aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control following Chronic Stroke: A Randomized Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0131048. doi: 10.1371/journal.pone.0131048. eCollection 2015.
PubMed 26193492
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Computer-aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control Following Chronic Stroke
- ClinicalTrials.gov ID
- NCT02247674
- Acronym / sponsor ID
- NYMU20140829
- Conditions
- Stroke, Cerebrovascular Accident, Cardiovascular Disease, Brain Injury
- Keywords
- Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chueh-Ho LinUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Sep 2014 (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 investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. In order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional performances, the investigators also hypothesized that motor recovery and functional performances improvements of paretic arm and hand have strongly correlation.
Detailed description
Objective: To investigate the training effects of interlimb force coupling training on paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the relationship between motor recovery of paretic hand, arm and functional abilities.
Design: A double-blind randomized controlled trial with outcome assessment at baseline and after 4 weeks intervention.
Setting: Department of physical medicine and rehabilitation in Taipei Veterans General Hospital.
Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were recruited and randomized assigned to training (n=16) and control group (n=17).
Interventions: Interlimb force coupling training task included different gripforce generation on the both hands.
Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function Test (WMFT). All assessment was executed by a blinded evaluator, and data management and statistical analysis was also conducted by a blinded statistic researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education & training consultation | Placebo comparator | Procedure: Bilateral movement trainingEducation and training consultations were provided for subjects in control group during study period. |
| Bilateral movement training | Experimental | Procedure: Bilateral movement trainingExercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions) |
Who may qualify
- Ages
- 28 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- at least 6 months since stroke
- three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
- ability to flex and extend the paretic arm and hand
- Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
- Mini-Mental State Examination (MMSE) score should 24 or higher
Key exclusion criteria (6 listed)
- unstable cardiovascular conditions
- uncontrolled hypertension (190/110 mm Hg)
- severe orthopedic or pain conditions
- dementia (Mini-Mental State Examination score < 22)
- aphasia with inability to follow researcher's commands
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 |
|---|---|---|
| Bilateral movement trainingAlso: Coupling movementExercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions) | Procedure or surgery | Bilateral movement training, Education & training consultation |
Primary outcome
Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
Time frame: before and after 4 weeks intervention
Outcome measure was assessed before and after 4 weeks intervention.
3 secondary outcomes
Barthel Index (BI)
Time frame: before and after 4 weeks intervention
Motor Assessment Score (MAS)
Time frame: before and after 4 weeks intervention
Wolf Motor Function Test (WMFT)
Time frame: before and after 4 weeks intervention
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 Sep 2014.
- Derived from this study: PubMed 26193492Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, Sung WH. Effects of Computer-Aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control following Chronic Stroke: A Randomized Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0131048. doi: 10.1371/journal.pone.0131048. eCollection 2015.
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A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
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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.
Wen-Hsu Sung, PhD study chair
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral movement training in people with Stroke and Cerebrovascular Accident, run by Chueh-Ho Lin at 1 site in Taiwan.
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 8 inclusion and 6 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 Sep 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 Taiwan. 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.
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?
Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE) (time frame: before and after 4 weeks intervention). 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 NCT02247674, 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 25 Sep 2014.