Robot-assisted Versus Conventional Physical Therapy for Hand... | Clinical Trial | StuddyBuddy@endsection
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NCT07615569
Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke
Conditions: Stroke, Spastic Hemiplegia, Upper Limb Motor Impairment
Sex: All
Ages: 30 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Montiha Azeem
Location: University of Lahore Teaching Hospital, Lahore Lahore Punjab Province
Summary
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
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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).
Source: ClinicalTrials.gov (NCT07615569). StuddyBuddy aggregates publicly available trial information.