- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05898971
Robotic Hand on Hand Functions in Strokes
June 7, 2025 updated by: Mariam Elsayed Mohamed Abd Alaal, Cairo University
Effect of Robotic Hand Versus Mirror Therapy on Hand Functions in Stroke Patients
robotic glove training could be a useful aid for these patients.
The aim of this study was to investigate the effect of Robotic gloves versus mirror therapy on Hand function in patients with cerebral vascular accident .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Post stroke patients aged over 40 years were randomly assigned into three groups (A and B ) Group .
Maximum hand grip strength, Hand and Fugl-Meyer Assessment-Upper Extremity (FMA-UE), were assessed at baseline, post-intervention, and six-month follow-up.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jeddah, Saudi Arabia, 32143
- Dr. Mariam Salem
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Spasticity level 1 or 1+ according to modified Ashworth scale
Exclusion Criteria:
Uncontrolled seizures hand fractures or surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
received robotic gloves training
|
Patients receive robotic training (grasp and grip)
|
|
Experimental: Group B
received mirror therapy
|
Patients receive mirror therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hand grip strength
Time Frame: 8 weeks, and six-month follow-up.
|
Hand Dynamometer will be used to evaluate the hand's grip strength
|
8 weeks, and six-month follow-up.
|
|
Hand manual function
Time Frame: 8 weeks, and six-month follow-up.
|
Box and block test for measuring the manual dexterity of patients
|
8 weeks, and six-month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time Frame: 8 weeks, and six-month follow-up.
|
It evaluates sensorimotor impairment
|
8 weeks, and six-month follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. Mariam Salem, Professor of Physical Therapy , Batterjee Medical College.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2023
Primary Completion (Actual)
August 2, 2023
Study Completion (Actual)
November 13, 2023
Study Registration Dates
First Submitted
May 21, 2023
First Submitted That Met QC Criteria
June 1, 2023
First Posted (Actual)
June 12, 2023
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 7, 2025
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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