- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425158
Differences in Treatment Characteristics and Patient and Therapist Satisfaction Between Robot Assisted Therapy and Conventional Occupational Therapy Among Individuals Post Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Raanana, Israel
- Loewenstein
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 85 year old following stroke (first-ever stroke).
- Individuals in the sub-acute phase (up to three months)
- Intact cognitive function (score > 21 points on the Mini Mental State Examination)
- Sever weakness of the affected upper limb (score 5-20 points on the FMA)
- Understanding and reading Hebrew
- Normal or corrected eyesight.
- Subjects were at least in one session of RAT and one session of COT
Exclusion Criteria:
- Neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restrict upper limb function.
- High muscle tone (score > 4 in Modified Ashworth Scale)
- Apraxia (score <68 in De Renzi Apraxia Test)
- Severe Sensory impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Therapy
Each subject will receive two 30-min treatment sessions, one Robot Assisted Therapy and one Conventional Occupational Therapy.
|
Robot Assisted Therapy (RAT): 30-min treatment session of active- assisted movements of shoulder and elbow, using a robotic arm and a computer screen, provides different exercises according to the motor ability of the patient. The robot provides proximal upper limb training in a three-dimensional (3D) environment. The occupational therapist will be planning the treatment by determining the range of motion, the amount of help and support and the level of difficulty of the game. Conventional occupational therapy (COT): 30-min treatment session of active- assisted movements of the shoulder and elbow, using conventional facilities and devices. Treatment includes passive range of motion exercises and active- assistive exercises. The level of support and help will be determined by the occupational therapist.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observation
Time Frame: 30 min
|
The number of repetitions and compensations will be counted by observation
|
30 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS
Time Frame: 1min
|
The Visual Analogue Scale (VAS) is a common scale for estimating pain level from one to ten.
|
1min
|
|
Questionnaire
Time Frame: 5 min
|
A subjective satisfaction questionnaire regarding the treatment will be administered.
|
5 min
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0020-20-LOE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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