Robotic Hand on Hand Functions in Strokes | NCT05898971

Studies
Robotic Hand on Hand Functions in Strokes

NCT05898971

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jun 11, 2025Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

CVA (Cerebrovascular Accident)

Interventions

Robotic
Mirror

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2023Actual

Primary Completion Date

Aug 2, 2023Actual

Completion Date

Nov 13, 2023Actual

First Submitted Date

May 21, 2023

First Submission Date that Met QC Criteria

Jun 1, 2023

First Posted Date

Jun 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2025

Last Update Posted Date

Jun 11, 2025Actual

Name	Class
Batterjee Medical College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	received robotic gloves training	Other: Robotic
Group B	Experimental	received mirror therapy	Other: Mirror

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic	Other	Patients receive robotic training (grasp and grip)	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)	It evaluates sensorimotor impairment	8 weeks, and six-month follow-up.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spasticity level 1 or 1+ according to modified Ashworth scale

Exclusion Criteria:

Uncontrolled seizures hand fractures or surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Mariam Salem	Professor of Physical Therapy , Batterjee Medical College.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Mariam Salem		Jeddah		32143	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012371	Robotics

Ancestor Terms

ID	Term
D001331	Automation
D013672	Technology
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided