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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07080099
Acronym
BIT
Enrollment
38
Registered
2025-07-23
Start date
2024-02-25
Completion date
2024-09-30
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, bimanual intensive training, sensory training

Brief summary

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.

Detailed description

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

Interventions

OTHERBIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING

Bimanual intensive therapy Bimanual coordination training ,Functional training of the hands ,Trask oriented training, Bilateral arm training, Passive sensory training: Electrical stimulation.

OTHERBIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING

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.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

the study would be single blinded as the assessor of the study would be kept blind of the treatment groups to which patients will be allocated.

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FUGAL MEYER ASSESSMENT (FMA)8 weeksThe 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.
NOTTINGHAM SENSORY ASSESSMENT8 weeksThe Nottingham Sensory Assessment is a standardized scale for assessing sensory impairment in stroke patients.
FUNCTIONAL INDEPENDENCE MEASURE (FIM)8 weeksThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026