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NCT Number: NCT07701577

Robotic-Assisted Training on Hand Function in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Fine Motor Skills Hand Function Impairment Nervous System Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Hand-held dynamometer for measuring hand strength

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

    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.

Secondary outcomes

  1. Fugl-Meyer Test (Upper limb impairment test)

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

    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.

  2. Jobson Hand function test

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

    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

  3. Jobson Hand function test

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

    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.

Sponsors and collaborators

Lead sponsor

Adly A Adam

Other

Registry information

Official study title

Robotic-Assisted Training on Hand Function in Stroke Patient

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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