Clinical trial NCT06927284: Effects Of Neurocognitive Therapy With And Without Soft Robotic Hand On Hand Function
Official title: Effects of Neurocognitive Therapy With and Without Soft Robotic Hand on Hand Function in Sub-acute Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Hand Function,cognitive, Stroke Rehabilitation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: To determine the effect of neurocognitive therapy with and without a soft robotic hand on manual ability, dexterity, strength, spasticity and upper limb function in sub-acute stroke.

Detailed description: Stroke is a global disease with high death rate and high disability caused by motor cortical damage. According to the calculations, there were approximately 13.68 million new increased stroke patients all over the world a year and about 70% of survivors had diﬀerent degrees of upper limb and hand movement dysfunction .The recovery rate of patients' motor function mainly depends on rehabilitation training. Therefore, due to individual diﬀerence of patients. Neurocognitive therapy is an effective therapy to improve and increase cognitive, sensory and motor function of upper limb. Robotic hand also help the function of weak hand muscle. Neurocognitive therapy with a robotic hand will have the potential to offer targeted, precise, and adaptable interventions, possibly increase the rehabilitation process compared to both interventions alone. Evaluating their relative efficacy will aid in refining and tailoring rehabilitation strategies for individuals recovering from acute stroke.

Eligibility 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.

Primary outcomes:
measure: Montreal cognitive assessment (MoCA): (cognition)
timeFrame: 12 Weeks
measure: Barthel Index (basic activities of daily living)
timeFrame: 12 Weeks
measure: Modified Ashworth Scale (MAS)( spasticity level of the upper limb)
timeFrame: 12 Weeks
measure: Erasmus MC Nottingham Sensory Assessment (ErNSA) (sensation and proprioceptive)
timeFrame: 12 Weeks
measure: ) Action Research Arm Test (grasping, grip- ping, pinching)
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sheikh Zayad Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Shazia Abdul Mateen
role: STUDY_CHAIR
References: