StrokeNCT07701577
Robotic-Assisted Training on Hand Function in Stroke
A study testing Robot-assisted training using the In motion robotic gym system and Conventional Physical Therapy Program in people with Stroke and Hand Function Impairment, run by Adly A Adam at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Hand Function Impairment, Fine Motor Skills
- What is being tested?
- Robot-assisted training using the In motion robotic gym system and Conventional Physical Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 30 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Hand Function Impairment, Fine Motor Skills
- Being tested
- Robot-assisted training using the In motion robotic gym system, Conventional Physical Therapy Program
- Keywords
- Robotic-assisted Training, Hand function, Stroke, Hand-held dynamometer, Fugle-Meyer test, Jobsen Hand Function Test
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted training using the In motion robotic gym systemDevice
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Measured: 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.
Measured: 1. Pre-Treatment at baseline of the study 2. Post-treatment of 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 May 2025
- Primary completion1 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled parallel clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Mushira H Darwish, Professor, Study chair, Cairo University; Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701577
- Sponsor's protocol ID
- P.T.REC/012/005776
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes