Neurocognitive therapy with or without a soft robotic hand to improve hand function after a stroke
Effects of Neurocognitive Therapy With and Without Soft Robotic Hand on Hand Function in Sub-acute Stroke
This trial tests whether adding a soft robotic hand to neurocognitive therapy helps people 6–12 weeks after a stroke regain hand strength, dexterity, reduce spasticity, and improve upper limb function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT06927284 on ClinicalTrials.gov |
What this trial studies
Adults 6–12 weeks after a first-ever stroke with mild spasticity and preserved cognition will receive neurocognitive therapy either combined with a wearable soft robotic hand or without the device. The interventions target manual ability, dexterity, muscle strength, spasticity, and overall upper-limb function using standard clinical scales and performance tests. Participants are selected for mild to moderate arm motor deficits and normal cognition and will undergo repeated in-person therapy sessions and outcome assessments. The single-center trial is conducted at Sheikh Zayed Hospital in Lahore to compare the relative benefit of adding a soft robotic hand to neurocognitive rehabilitation in the sub-acute period.
Who should consider this trial
Good fit: Ideal candidates are adults 6–12 weeks after a first stroke with mild arm spasticity (Modified Ashworth Scale <2), intact cognition (MoCA >24), and measurable arm motor deficit.
Not a fit: Patients with severe cognitive impairment or aphasia, high spasticity, significant comorbid neurological or orthopedic disorders, severe arm pain, or active implanted devices (e.g., pacemakers) are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, combining a soft robotic hand with neurocognitive therapy could speed and improve recovery of hand and arm function after stroke.
How similar studies have performed: Robotic-assisted rehabilitation and neurocognitive therapies have each shown benefits for upper-limb recovery in prior studies, but combining a soft robotic hand with neurocognitive therapy is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants of Post stroke patients (6-12 weeks ) * Participants with Spasticity \< 2 on modified Ashworth scale. * Participants with first ever stroke. * Participants with normal cognition \> 24 on MoCA * Participants must be able to provide informed consent * Hemiparesis with arm motor deficit as assessed by with NIHSS \>1(14) Exclusion Criteria: * Participants who have a history of significant neurological or orthopedic disorders, other than stroke, that could interfere with upper limb motor or sensory recovery. * Participants who have altered state of consciousness, severe aphasia, severe cognitive deficit. * Participants who have severe pathologies of traumatic and or rheumatic nature, severe pain in effected arm (\>5 on visual analog scale for pain) . * Participants who have active pacemakers and other active implants.
Where this trial is running
Lahore, Punjab Province
- Sheikh Zayad Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Aruba Saeed, PhD* — Riphah International University
- Study coordinator: Shazia Abdul Mateen, PhD
- Email: aruba.saeed@riphah.edu.pk
- Phone: 03344399403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.