Rehabilitation, Tenodesis, Stroke Clinical Trial
Official title:
Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation for Upper Extremity Function of Stroke Patients
| Verified date | March 2023 |
| Source | National Cheng-Kung University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In the proposed study, the investigators assumed that using robot assisted tenodesis-grip training providing high does assisted grip movement may do the effects on motor shaping and greater brain priming for hand paresis of the stroke patients. The specific aim of this study is to examine the difference in the treatment effects between the combination of robot assisted tenodesis-grip training with task-oriented training and combination of traditional occupational therapy with task-oriented training on the motor, sensation, hand performance of the stroke patients. The expected outcomes of this research are to help the clinicians understand the training mechanism and effects of robot assisted tenodesis-grip training on functional performance of upper extremity for unilateral stroke patients.
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | March 20, 2024 |
| Est. primary completion date | March 20, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility | Inclusion Criteria: 1. Clinical diagnosis of stroke with unilateral side involved; 2. Stroke at least 7 days before the start of the first assessment session; 3. A score of Mini-mental state examination greater than 24 for proving higher mental function; 4. Premorbid right-handedness. Exclusion Criteria: 1. Uncontrolled hypertension; 2. Major cognitive-perceptual deficit; 3. Other brain disease. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Cheng-Kung University Hospital | Tainan |
| Lead Sponsor | Collaborator |
|---|---|
| National Cheng-Kung University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the result of Fugl-Meyer assessment for UE motor function | Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity. | baseline, 6 weeks and 18 weeks | |
| Primary | Change in the result of Modified Ashworth scale (MAS) | Muscle tone is defined by the resistance of a muscle being stretched without resistance. | baseline, 6 weeks and 18 weeks | |
| Primary | Change in the result of Box and blocks test | The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. | baseline, 6 weeks and 18 weeks | |
| Primary | Change in the result of Semmes-Weinstein monofilament (SWM) test | The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome. | baseline, 6 weeks and 18 weeks | |
| Primary | Change in the result of Motor Activity Log | MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale. | baseline, 6 weeks and 18 weeks | |
| Secondary | Clinical global impression scale | Self-reported improvement over the treatment period,. The scale, rated from 1 (very much improved) to 7 (very much worse), is as the indicator for determining perceptible change of the patients for assisted tenodeis-grip robot system. | post-intervention (week 6) |