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

Riphah International University

Status: Completed

Conditions: Stroke

Treatments: Other: BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING; Other: BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING

Study type: Interventional

Funder types: Other

Identifiers

NCT07080099

REC/RCR&AHS/24/0236

Details and patient eligibility

About

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.

Full 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

Enrollment: 38 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Bimanual intensive with passive sensory training

Experimental group

Description:

Group A will receive bimanual intensive therapy with sensory training of 45 minutes with short resting intervals. Treatment will be given 3 times per week for 8 weeks.

Treatment:

Other: BIMANUAL INTENSIVE THERAPY WITH PASSIVE SENSORY TRAINING

Bimanual intensive with active sensory training

Experimental group

Description:

Group B will receive bimanual intensive therapy with active sensory training of 45 minutes with short resting interval given to the patient. The treatment will be given 3 times per week for 8 weeks.

Treatment:

Other: BIMANUAL INTENSIVE THERAPY WITH ACTIVE SENSORY TRAINING