NCT05898971

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 21, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
Last Updated

June 11, 2025

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

May 21, 2023

Last Update Submit

June 7, 2025

Conditions

CVA (Cerebrovascular Accident)

Keywords

StrokeHand Grip Strength

Outcome Measures

Primary Outcomes (2)

  • hand grip strength

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

    8 weeks, and six-month follow-up.

  • Hand manual function

    Box and block test for measuring the manual dexterity of patients

    8 weeks, and six-month follow-up.

Secondary Outcomes (1)

  • Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

    8 weeks, and six-month follow-up.

Study Arms (2)

Group A

EXPERIMENTAL

received robotic gloves training

Other: Robotic

Group B

EXPERIMENTAL

received mirror therapy

Other: Mirror

Interventions

RoboticOTHER

Patients receive robotic training (grasp and grip)

Group A
MirrorOTHER

Patients receive mirror therapy

Group B

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spasticity level 1 or 1+ according to modified Ashworth scale

You may not qualify if:

  • Uncontrolled seizures hand fractures or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Mariam Salem

Jeddah, 32143, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Interventions

Robotics

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Dr. Mariam Salem

    Professor of Physical Therapy , Batterjee Medical College.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Comparative trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2023

First Posted

June 12, 2023

Study Start

April 12, 2023

Primary Completion

August 2, 2023

Study Completion

November 13, 2023

Last Updated

June 11, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)