Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorMontiha Azeem
About this trial
This randomized controlled trial aims to compare the effectiveness of robotic-assisted physiotherapy and conventional physiotherapy in improving hand function among patients with sub-acute stroke. Stroke often results in weakness, reduced hand strength, impaired dexterity, and difficulty performing daily activities due to upper-limb motor dysfunction. Early rehabilitation targeting hand recovery is essential to improve independence and quality of life.
A total of 30 participants with sub-acute post-stroke spastic hemiplegia will be recruited from the University of Lahore Hospital and randomly assigned into two groups. The intervention group will receive robotic-assisted physiotherapy focused on repetitive, task-specific wrist and finger extension training using a robotic hand/wrist device, while the control group will receive conventional therapist-led upper-limb rehabilitation exercises. Both groups will undergo treatment sessions lasting 30-45 minutes, five days per week for four weeks.
Outcome measures will include hand muscle strength assessed using a hand-held dynamometer, hand dexterity evaluated through the Action Research Arm Test (ARAT), and functional improvement measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Additional measures such as spasticity, activities of daily living, and quality of life will also be recorded. Assessments will be conducted at baseline, during treatment, and after completion of the intervention period by a blinded assessor.
The study is expected to determine whether robotic-assisted physiotherapy provides greater improvements in hand strength, dexterity, and upper-limb functional recovery compared to conventional physiotherapy in individuals recovering from stroke. Findings from this research may contribute to evidence-based rehabilitation strategies for improving upper-limb outcomes after stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both male and female adults aged 30-50 years diagnosed with post-stroke spastic hemiplegia confirmed by a neurologist.
Stroke duration 2 weeks to 6 months (sub acute stage) with medically stable condition.
Presence of mild to moderate upper-limb spasticity using screening test(Modified Ashworth Scale score 1-3).
Ability to comprehend and follow simple verbal instructions using screening test (MMSE ≥ 24).
Disqualifiers
No history of upper-limb orthopedic surgery or botulinum toxin injections in the last 6 months.
History of recurrent or uncontrolled seizure disorders, progressive neurological diseases, or unstable cardiovascular conditions.
Participation in any intensive upper-limb rehabilitation program (CIMT, bimanual training, task-specific training, robotic therapy, FES therapy) within the past 6 months.
Comorbid conditions affecting upper-limb function (fractures, severe arthritis, peripheral nerve injuries).
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic-Assisted Hand Rehabilitation Therapy
DeviceParticipants will receive robotic-assisted hand rehabilitation using a robotic hand/wrist training device designed to improve wrist and finger extension, hand coordination, and functional upper-limb recovery after stroke. The intervention will include repetitive task-specific movements, active-assist and active-resist training, grasp-release exercises, visual feedback activities, and functional motor practice supervised by a physiotherapist. Treatment intensity and robotic assistance will be progressively adjusted according to patient performance and recovery level. Sessions will last 30-45 minutes, 5 days per week for 4 weeks.
Conventional Physiotherapy
Procedure/SurgeryParticipants will receive conventional physiotherapy focused on upper-limb rehabilitation after stroke. The treatment program will include active-assisted and active range-of-motion exercises, strengthening exercises for wrist and finger extensors, task-specific functional training, neuromuscular facilitation techniques, mirror therapy, and activities of daily living practice. Exercise intensity and task difficulty will be progressively increased according to patient ability and motor recovery. Sessions will last 30-45 minutes, 5 days per week for 4 weeks under physiotherapist supervision.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: group A Robotic-Assisted Physiotherapy GroupExperimental treatment 1 intervention
Group B: group B Conventional Physiotherapy GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Upper Limb Motor Function Using Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor recovery and functional improvement of the affected upper limb in participants with sub-acute stroke. The assessment includes evaluation of reflexes, movement synergy, wrist control, hand function, and coordination. Higher scores indicate better upper-limb motor performance and recovery.
Time frame
Baseline and after 4 weeks of interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Montiha Azeem
Lead sponsor
University of Lahore
Sponsor institution
Source ClinicalTrials.gov