Effects Of Neurocognitive Therapy With And Without Soft Robotic Hand On Hand Function

NCT ID: NCT06927284

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-10-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Neurocognitive Therapy with Soft Robotic Hand based

Neurocognitive therapy group with soft robotic hand for 30 minutes along routine physical therapy for 15 minutes , the participants will be blindfolded during the exercises and ask to concentrate on sensing the position of the limb and hand Opening and closing of the soft robotic glove is controlled by the hand control switch .Treatment session of 45 minutes will be given 3 times a week for 12 week.

Group Type: EXPERIMENTAL

Neurocognitive Therapy without Soft Robotic Hand

Intervention Type: OTHER

There will be 23 participants received Neurocognitive Therapy without soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object will be repositioned, and another object of a different shape or size will be offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object .

Neurocognitive Therapy without Soft Robotic Hand based

Neurocognitive therapy group without soft robotic hand for 30 minutes along routine physical therapy for 15 minutes , the participants will be blindfolded during the exercises and ask to concentrate on sensing the position of the limb and hand Opening and closing of the soft robotic glove is controlled by the hand control switch .Treatment session of 45 minutes will be given 3 times a week for 12 week.

Group Type: EXPERIMENTAL

Neurocognitive Therapy with Soft Robotic Hand

Intervention Type: OTHER

There will be 23 participants received Neurocognitive Therapy with soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object repositioned, and another object of a different shape or size offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object with soft robotic hand.

Interventions

Neurocognitive Therapy with Soft Robotic Hand

There will be 23 participants received Neurocognitive Therapy with soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object repositioned, and another object of a different shape or size offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object with soft robotic hand.

Intervention Type: OTHER

Neurocognitive Therapy without Soft Robotic Hand

There will be 23 participants received Neurocognitive Therapy without soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object will be repositioned, and another object of a different shape or size will be offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object .

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Shazia Abdul Mateen

Role: STUDY_CHAIR

Riphah International University

Locations

Sheikh Zayad Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Shazia Abdul Mateen, PhD

Role: CONTACT

aruba.saeed@riphah.edu.pk

03344399403

Aruba Saeed, Phd*

Role: CONTACT

arubasaeedpt@gmail.com

03344399403

Facility Contacts

Aruba Saeed, PhD

Role: primary

aruba.saeed@riphah.edu.pk

03344399403

Other Identifiers

REC/0217 Shazia

Identifier Type: -

Identifier Source: org_study_id