Robotic Hand on Hand Functions in Strokes

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05898971

Collaborator

Batterjee Medical College (Other)

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

robotic glove training could be a useful aid for these patients. The aim of this study was to investigate the effect of Robotic gloves on Hand function in patients with cerebral vascular accident .

Condition or Disease	Intervention/Treatment	Phase
CVA (Cerebrovascular Accident)	Other: Robotic Other: Traditional Physical Therapy	N/A

Detailed Description

Post stroke patients aged over 40 years were randomly assigned into two groups (A and B). Group . Maximum hand grip strength and Hand function were assessed before and after the intervention using hand dynamometer and box and block test respectively.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Control trialRandomized Control trial

Masking:

Single (Outcomes Assessor)

Masking Description:

single blind

Primary Purpose:

Treatment

Official Title:

Effect of Robotic Hand on Hand Functions in Stroke Patients

Actual Study Start Date :

Apr 12, 2023

Anticipated Primary Completion Date :

Jul 2, 2023

Anticipated Study Completion Date :

Aug 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study received robotic gloves training	Other: Robotic Patients receive robotic training (grasp and grip)
Active Comparator: Control received traditional physical therapy	Other: Traditional Physical Therapy Traditional exercise and Neurophysiological approaches

Arm

Intervention/Treatment

Experimental: Study

received robotic gloves training

Other: Robotic

Patients receive robotic training (grasp and grip)

Active Comparator: Control

received traditional physical therapy

Other: Traditional Physical Therapy

Traditional exercise and Neurophysiological approaches

Outcome Measures

Primary Outcome Measures

hand grip strength [8 weeks]
Hand Dynamometer will be used to evaluate the hand's grip strength
Hand manual function [8 weeks]
Box and block test for measuring the manual dexterity of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Spasticity level 1 or 1+ according to modified Ashworth scale

Exclusion Criteria:

Uncontrolled seizures hand fractures or surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Mariam Salem	Jeddah		Saudi Arabia	32143

Sponsors and Collaborators

Cairo University
Batterjee Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mariam Elsayed Mohamed Abd Alaal, Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05898971

Other Study ID Numbers:

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mariam Elsayed Mohamed Abd Alaal, Professor, Cairo University

Stroke

Hand Grip Strength

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 12, 2023