Robotic-Assisted Training on Hand Function in Stroke

NCT07701577 | Completed DMC

• 1 other identifier: P.T.REC/012/005776
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system. A key component of stroke rehabilitation is improving upper limb function to reduce impairments and disabilities. A task-specific approach retraining for upper extremity control seeks to minimize impairments while maximizing the patient's functional performance. Technology-supported training is emerging to help therapists, patients, and the health system. Robotic devices allow to facilitate and control the complexity of a motor task. The benefits of robotic rehabilitation affect both therapists and patients: robot-assisted therapy can increase treatment compliance by way of introducing games or interactive upper limb tasks and patients can train independently with less supervision from therapists. Therefore, this study was conducted in line to determine the effect of robotic-assisted training on hand function in patients following a stroke.

Conditions

Stroke; Hand Function Impairment; Fine Motor Skills

Keywords

Robotic-assisted Training; Hand function; Stroke; Hand-held dynamometer; Fugle-Meyer test; Jobsen Hand Function Test

Outcome Measures

Primary Outcomes (1)

• Hand-held dynamometer for measuring hand strength

  Handheld dynamometer (Item model number:EH101, Manufacturer: Handeful), it is equipped with high precision strain gauge sensor that provides an accurate momentary digital reading of gripping power with a maximum capacity 198ibs - 90kgm. It is easy to read as it includes a large LCD screen that displays all measurements. It is used for measuring hand strength, while patient was seated comfortably, then was asked to place the arms by sides with his\\her elbow in a 90-flexion position in neutral, then instructed to squeeze the digital hand dynamometer as hard as possible for 3 seconds, the test was repeated 2 more times and the mean handgrip strength of the 3 attempts were recorded.

  1. Pre-treatment at base-line of the study. 2. Post-treatment after 12 weeks of intervention.

Secondary Outcomes (3)

• Fugl-Meyer Test (Upper limb impairment test)

  1. Pre-treatment at base-line 2. Post-treatment after 12 weeks of intervention

• Jobson Hand function test

  1. Pre-treatment at baseline of the study 2. Post-treatment after 12 weeks of intervention

• Jobson Hand function test

  1. Pre-Treatment at baseline of the study 2. Post-treatment of 12 weeks of intervention

Study Arms (2)

Study Group (A)

EXPERIMENTAL

Received Robot-assisted training of a selected physical therapy program using Multifunctional intelligent instrument system for 45 minutes, three times per week, for 12 week.

Device: Robot-assisted training using the In motion robotic gym system

Control Group (B)

ACTIVE COMPARATOR

Received Conventional physical therapy program for 1 hour per session, three times per week, for12 weeks. Passive, active assisted, and active range of motion exercises for affected upper extremity for 30 minutes, Facilitation and inhibition techniques, plus neuromuscular electrical stimulation for wrist extensors for 30 minutes.

Other: Conventional Physical Therapy Program

Interventions

Robot-assisted training using the In motion robotic gym system DEVICE

The Hand Wrist Assistive Rehabilitation Device or HWARD: 'exoskeleton with 3 degrees of freedom (flexion-extension of the fingers, thumb and wrist) that assists (through pneumatic actuators) the hand in the" grasp and release "movement. The patient is seated in front of a monitor, the hand is secured to the robot by three soft Velcro strips, The palm of the hand is left free allowing the grasping of real objects, as well as virtual ones. Its a 45 minutes session , three times per week, for 12 weeks.

Study Group (A)

Conventional Physical Therapy Program OTHER

Passive, active-assisted, and active range of motion, and facilitation/inhibition techniques for 30 minutes, also Neuromuscular electrical stimulation for wrist extensors, and task-oriented exercise training for strengthening foe 30 minutes.

Control Group (B)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranged from 40 to 60 years old.
• Clinical diagnosis of ischemic stroke and diagnosis confirmed by CT or MRI with hand impairments.
• Stroke started since six months (at chronic stage)
• Mild to moderate upper limb functional limitation according to (Fugl-Meyer score: 85-99).
• Ability to understand and follow instructions and to provide informed consent.

You may not qualify if:

• More than one stroke.
• Other current significant impairment of the upper limb affected by stroke, e.g. fixed contracture, frozen shoulder, severe arthritis, recent fracture.
• Diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. registered blind.
• Previous use of the InMotion robotic gym system or other arm rehabilitation robot.
• Current participation in a rehabilitation trial evaluating upper limb rehabilitation after stroke

Sponsors & Collaborators

• Adly A Adam: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 11432, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mushira H Darwish, Professor

  Cairo University; Faculty of Physical Therapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double masking 'Investigator, and Outcome assessor'
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapy Specialist

Model Details: A randomized controlled parallel clinical trial

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: May 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 30, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)