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Robotic Hand on Hand Functions in Strokes

Primary Purpose

CVA (Cerebrovascular Accident)

Status

Active

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Robotic

Mirror

Traditional Physical Therapy

About this trial

This is an interventional treatment trial for CVA (Cerebrovascular Accident) focused on measuring Stroke, Hand Grip Strength

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Spasticity level 1 or 1+ according to modified Ashworth scale Exclusion Criteria: Uncontrolled seizures hand fractures or surgery

Sites / Locations

Dr. Mariam Salem

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

received robotic gloves training

received mirror therapy

received traditional physical therapy

Outcomes

Primary Outcome Measures

hand grip strength

Hand Dynamometer will be used to evaluate the hand's grip strength

Hand manual function

Box and block test for measuring the manual dexterity of patients

Secondary Outcome Measures

Full Information

NCT ID

NCT05898971

First Posted

May 21, 2023

Last Updated

September 4, 2023

Sponsor

Cairo University

Collaborators

Batterjee Medical College

1. Study Identification

Unique Protocol Identification Number

NCT05898971

Brief Title

Robotic Hand on Hand Functions in Strokes

Official Title

Effect of Robotic Hand Versus Mirror Therapy on Hand Functions in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 12, 2023 (Actual)

Primary Completion Date

August 2, 2023 (Actual)

Study Completion Date

October 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Batterjee Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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 versus mirror therapy on Hand function in patients with cerebral vascular accident .

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CVA (Cerebrovascular Accident)

Keywords

Stroke, Hand Grip Strength

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Control trial

Masking

Outcomes Assessor

Masking Description

single blind

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

received robotic gloves training

Arm Title

Group B

Arm Type

Experimental

Arm Description

received mirror therapy

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

received traditional physical therapy

Intervention Type

Other

Intervention Name(s)

Robotic

Intervention Description

Patients receive robotic training (grasp and grip)

Intervention Type

Other

Intervention Name(s)

Mirror

Intervention Description

Patients receive mirror therapy

Intervention Type

Other

Intervention Name(s)

Traditional Physical Therapy

Intervention Description

Traditional exercise and Neurophysiological approaches

Primary Outcome Measure Information:

Title

hand grip strength

Description

Hand Dynamometer will be used to evaluate the hand's grip strength

Time Frame

8 weeks

Title

Hand manual function

Description

Box and block test for measuring the manual dexterity of patients

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Spasticity level 1 or 1+ according to modified Ashworth scale Exclusion Criteria: Uncontrolled seizures hand fractures or surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Mariam Salem

Organizational Affiliation

Professor of Physical Therapy , Batterjee Medical College.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Mariam Salem

City

Jeddah

ZIP/Postal Code

32143

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

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Robotic Hand on Hand Functions in Strokes

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