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NCT Number: NCT07080099

Effects of Bimanual Intensive Therapy With Sensory Training in Post Stroke Patients

Stroke is the major serious health burden and the leading cause of serious long term disability around the world. One of the most cumbersome deficits after a stroke is impairment in the contralateral upper limb. Bimanual intensive therapy (BIT) is a specialized approach used in rehabilitation for individuals, typically children, who have hemiplegia or hemiparesis, which means weakness or paralysis on one side of the body A therapy strategy known as "sensory training" aims to improve sensory integration and processing in people who struggle with sensory processing issues. The aim of this study is to determine the combined effects of bimanual intensive therapy with sensory training in addition conventional therapy on motor functions, sensory function and functional independence stroke patients.

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Key information

Conditions

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

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhammad kashif

Lahore, Punjab Province, 54600, Pakistan

About this study

This randomized clinical trial, will be conducted at jinnah hospital Lahore. For this study, the estimated sample size will be 38. The participants will be randomly allocated using online randomization tool into two groups; group A will receive the bimanual intensive training with passive sensory training for 45 minutes. Group B will receive bimanual intensive training with active sensory training for 45 minutes. Each participants will receive treatment for three days on alternative days for 8 weeks.

Fugal Meyer assessment will be used to asses' motor function. Nottingham Sensory assessment will be used to asses' sensory functions and Functional independence measure for activities of daily living. The data will be entered and analyzed using SPSS 26. Statistical significance will be set at p=0.05. Normality of data will be assessed through kolmogrove-smirnov test and shapirno-wilk test. Assessment will be carried out at bassline, 4th week and 8th week follow-up. For between group analyses of parametric data independent T test will be used, while Man Whitney test will be used for non-parametric data. For within groups comparison repeated measure Annona will be used, for non-parametric, Freidman Annona will be applied

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with age group 45 to 65
  • Both genders
  • Patients with stroke that was diagnosed clinically and/ or by computed tomography (CT) or magnetic resonance imaging
  • Patient with stable vital signs and GCS score >8-15
  • Patients with mini mental state examination score>24(30)

Exclusion criteria

  • Patients with severe cardiopulmonary complications
  • Patients with history of epilepsy
  • Patients with the presence of a pacemaker
  • Patients with an history of an intracranial implant
  • Patients with presence of a cranial defect
  • Any other neurological conditions

Treatment and study plan

BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING

Other

Bimanual intensive therapy Bimanual coordination training ,Functional training of the hands ,Trask oriented training, Bilateral arm training,

Passive sensory training:

Electrical stimulation.

BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING

Other

Bimanual intensive therapy:

  • Bimanual coordination training ,Functional training of the hands
  • Trask oriented training, bilateral arm reaching

Active sensory training:

sensory re education techniques ,touching different objects, massage, identifying different temperatures, and sensory locating.

Primary outcomes

  1. FUGAL MEYER ASSESSMENT (FMA)

    Time frame: 8 weeks

    The FMA assessment contained 33 items (divided into nine domains) regarding different movements, reflexes, and coordination. The assessment includes functional classes of upper extremity reflex activities, flexor synergy motion, extensor synergy motion, activities that were accompanied by synergy motion, disengaging movement, normal reflex action, and carpal joint stability.

  2. NOTTINGHAM SENSORY ASSESSMENT

    Time frame: 8 weeks

    The Nottingham Sensory Assessment is a standardized scale for assessing sensory impairment in stroke patients.

  3. FUNCTIONAL INDEPENDENCE MEASURE (FIM)

    Time frame: 8 weeks

    The Functional Independence Measure (FIM) is an instrument that was developed as a measure of a disability of populations. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Bimanual Intensive Therapy With Sensory Training on Motor Function, Sensory Function and Functional Independence in Post Stroke Patients

Acronym: BIT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2025
Registry last updated
Jul 23, 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.

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