Robotic-Assisted Training on Hand Function in Stroke

Robotic-Assisted Training on Hand Function in Stroke Patient

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Fine Motor Skills; Hand Function Impairment
• Intervention / Treatment: Device: Robot-assisted training using the In motion robotic gym system; Other: Conventional Physical Therapy Program

Detailed Description

Stroke is the leading cause of complex adult disability with arm function impairment affecting approximately 69% of stroke survivors. Enhancing arm function is a priority for stroke survivors, caregivers, and healthcare professionals, as current rehabilitation approaches often neglect arm recovery. In Motion robotic gym system represents an effective treatment option for improving upper limb function in patients' post-stroke, owing to its ease of application, cost-effectiveness, and tolerability. Rehabilitation robotics is an emerging research domain aimed at leveraging cutting-edge robotic technology and virtual reality systems for the rehabilitation of neurological patients. While clinical trials in post-stroke patients with upper limb impairments have yielded positive results regarding motor recovery, they have shown limited efficacy concerning functional outcomes. Thus, there remains a pressing need to develop a new generation of rehabilitation robots and clinical protocols that can more effectively assist patients in regaining their abilities in activities of daily living. Therefore, this study was conducted in line to determine the effect of robotic-assisted training 'course of 12 weeks' on hand function 'assessing strength, via dynamometer, function via Fugle-Meyer test, and overall function via Jobson hand function' in patients following a stroke.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11432
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group (A); 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; 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.
Active Comparator: Control Group (B); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Test (Upper limb impairment test)	Fugl-Meyer Test is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It takes approximately 30-35 minutes, Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. Noting 0-35: Very severe, 6-55: Severe, 56-79: Moderate, more than 79 indicates mild in the scoring system.	1. Pre-treatment at base-line 2. Post-treatment after 12 weeks of intervention
Jobson Hand function test	It is a health and care, UK, that is a used to evaluate the functional capabilities using a stopwatch. It includes seven items: picking up small common objects, card turning, simulated feeding (bean spooning), picking up large light objects, stacking checkers, picking up large heavy objects, and writing a short sentence. The time of performance was recorded for each test. Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance	1. Pre-treatment at baseline of the study 2. Post-treatment after 12 weeks of intervention
Jobson Hand function test	Using a stop watch for scoring and evaluating the functional capabilities of patients. This test includes seven items: picking up small common objects, card turning, simulated feeding (bean spooning), picking up large light objects, stacking checkers, picking up large heavy objects, and writing a short sentence. The time of performance was recorded for each test Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.	1. Pre-Treatment at baseline of the study 2. Post-treatment of 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Adly A Adam
• Investigators: Study Chair: Mushira H Darwish, Professor, Cairo University; Faculty of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Hand function; Hand-held dynamometer; Robotic-assisted Training; Fugle-Meyer test; Jobsen Hand Function Test
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: P.T.REC/012/005776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No