Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06927284

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayad Hospital

Lahore, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Aruba Saeed, PhD

CONTACT

[email protected]

03344399403

Shazia Abdul Mateen, MS NMPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurocognitive Therapy with Soft Robotic Hand

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.

Neurocognitive Therapy without Soft Robotic Hand

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 .

Primary outcomes

  1. Montreal cognitive assessment (MoCA): (cognition)

    Time frame: 12 Weeks

    The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. Inter-rater Reliability (0.96) Cronbach's alpha .Change will be measured from baseline to 12 weeks.

  2. Barthel Index (basic activities of daily living)

    Time frame: 12 Weeks

    The BI is a measure of functional status whose validity when used on a general population of older people has been shown . The BI uses 10 items . Of the 10 items, two (bathing and grooming) are rated on a two-point scale of 0 and 1, six (feeding, dressing, bowels, bladder, toilet use and stairs) on a three-point scale of 0, 1 and 2 and the last two items (transfers and mobility) are rated on a four-point scale of 0, 1, 2 and 3. Change will be measured from baseline to 12 weeks.

  3. Modified Ashworth Scale (MAS)( spasticity level of the upper limb)

    Time frame: 12 Weeks

    The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. In 1987, while performing a study to exam interrater reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the Ashworth scale by adding 1+ to the scale to increase sensitivity. Change will be measured from baseline to 12 weeks.

  4. Erasmus MC Nottingham Sensory Assessment (ErNSA) (sensation and proprioceptive)

    Time frame: 12 Weeks

    The ErNSA is a specialized assessment tool designed to evaluate tactile sensation and proprioceptive ability in the upper limb. It consists of various subtests that provide a detailed examination of sensory function, contributing valuable insights into the sensory recovery post stroke of the upper limb).Change will be measured from bassline to 12 weeks.

  5. ) Action Research Arm Test (grasping, grip- ping, pinching)

    Time frame: 12 Weeks

    The ARAT is a hierarchical scale for the evaluation of arm-hand capacity. It consists of 19 functional items that are divided into 4 subtests: grasp, pinch, grip, and gross motor function. A total score of 57 indicates normative performance. The reliability and validity of the ARAT for patients with stroke have been established. on ARAT scores and subsequently classified into 5 different categories: 0 to 10 points as no capacity, 11 to 21 points as poor capacity, 22 to 42 points as limited capacity, 43 to 54 points as notable capacity, and 55 to 57 points as full capacity. Change will be measured from baseline to 12 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Aruba Saeed, Phd*

CONTACT

[email protected]

03344399403

Shazia Abdul Mateen, PhD

CONTACT

[email protected]

03344399403

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Neurocognitive Therapy With and Without Soft Robotic Hand on Hand Function in Sub-acute Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.