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

Overview

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.

Interventions

• Other 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 b
• 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, cotto

Primary outcome measures

• Montreal cognitive assessment (MoCA): (cognition) [Time frame: 12 Weeks]
• Barthel Index (basic activities of daily living) [Time frame: 12 Weeks]
• Modified Ashworth Scale (MAS)( spasticity level of the upper limb) [Time frame: 12 Weeks]
• Erasmus MC Nottingham Sensory Assessment (ErNSA) (sensation and proprioceptive) [Time frame: 12 Weeks]
• ) Action Research Arm Test (grasping, grip- ping, pinching) [Time frame: 12 Weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Sheikh Zayad Hospital — Lahore

Identifiers

NCT: NCT06927284 · REC/0217 Shazia

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗