Stroke
Conditions
Keywords
Stroke, Hand, Upper Extremity, Robotics
Brief summary
The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.
Detailed description
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system. Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour. During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy. There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.
Interventions
DEVICEHand Robotic Training
Training for 20 sessions for one hour, 3-5 times per week.
DEVICEHand and Arm Robotic Training
Training for 20 sessions for one hour, 3-5 times per week.
OTHERConventional therapy
Training for 20 sessions for one hour, 3-5 times per week.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
Exclusion criteria
* Excessive spasticity of the affected arm * Participation in any therapeutic treatment (outside therapy) performed with the paralyzed arm during the planned study - including baseline and follow up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment | Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months | Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
| Action Research Arm Test | Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months | Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test | Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months | Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
| modified Ashworth Scale | Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months | Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Countries
Hong Kong
Outcome results
None listed