A study to compare the effect of two therapies on the improvement of hand functions in stroke patients.

Phase 3

Recruiting

• Conditions: Cerebral infarction, unspecified,

• Registration Number: CTRI/2023/06/054543
• Lead Sponsor: Ranu Mukherjee

Brief Summary

PURPOSE OF THE STUDY :

There are various studies available which have found that the EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy are effective individually in improving the functional performance of hand in patients with hemiplegia. However, to the best of our knowledge there are no studies which have compared the efficacy of EMG Biofeedback Therapy and Modified  Constraint Induced Movement Therapy on hand functions in patients with hemiplegia. Therefore, the purpose of this study is to compare the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia

AIM:

The aim of this study is to compare the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.

OBJECTIVES:

1. To find out the efficacy of EMG Biofeedback Therapy on hand functions in patients with hemiplegia.

2. To find out the efficacy of Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.

3. To compare the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia

HYPOTHESIS:

NULL HYPOTHESIS (H0) -

There is no statistically significant difference between the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.

ALTERNATIVE HYPOTHESIS (H1) -

There is statistically significant difference between the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.

PROCEDURE:

Approval from the Institutional Ethical Committee (IEC) will be taken before the commencement of the study. All patients diagnosed with hemiplegia after stroke, referred to the Department of Physiotherapy from the Assessment Clinic of the National Institute for Locomotor Disabilities (Divyangjan) will be approached with the proposal of the study. A minimum of 30 patients with hemiplegia after stroke will be assessed and selected according to the inclusion and exclusion criteria. Those fulfilling the inclusion criteria will be informed and explained in detail about the study in their preferable and most communicable language. Informed consent written in their preferred language will be obtained from the patients who are willing to participate. Then the patients will be randomly divided into two groups with a minimum of 15 patients in each group using block randomization method by computer generated random block. The demographic data and outcome measure data will be collected from each patient for Active Range of Motion of the wrist extension by Universal Goniometer, Maximum Voluntary Isometric Contraction value of wrist extensor measured by EMG and Functional Performance using Fugl-Meyer Assessment Scale will be taken at baseline and the end of 16 sessions of intervention. In ‘Group-A’ (n≥15) EMG Biofeedback Therapy with Task Oriented Training and Standardized Exercise Program will be given for 16 sessions (4 sessions

per week for 4 weeks) and in ‘Group-B’ (n≥15) Modified Constraint Induced Movement Therapy with Task Oriented Training and Standardized Exercise Program will be provided for 16 sessions (4 sessions per week for 4 weeks). All the patients of both groups will be given Home Care Advice. Post-intervention data will be collected after 16 sessions from both the groups. Rescue medicines prescribed by the Physician will be continued in both the groups along with a physiotherapeutic approach.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-09
• Study Start: 2023-10-07

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Both male and female patients aged between 45-65 years.
• The first attack of stroke diagnosed by Physician.
• Three months to three years post stroke cases.
• Patient with no cognitive deficit (Mini Mental State Examination score 24 or higher).
• Brunnstrom hand recovery stage 4 and 5.
• Patient should have the initiation of active wrist extension.
• Spasticity grade up to 2 on Modified Ashworth Scale in upper extremity.

Exclusion Criteria

• Severe pain in the affected arm (Numeric Pain Rating Scale score above 6).
• Shoulder subluxation grade more than 2.
• Patients diagnosed with aphasia, auditory and visual defect.
• Diagnosed Neurological disorder like Parkinson’s Disease, CRPS, Peripheral Neuropathies etc.
• affecting upper extremity.
• Musculoskeletal conditions like fracture, contracture or deformities affecting upper extremity.
• Any sensory impairment in the involved upper extremity.
• Patients with hemineglect.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Active Range of Motion of wrist extension measured by Universal Goniometer.	4 weeks
2.Maximum Voluntary Isometric Contraction (MVIC) value of wrist extensor	4 weeks
3.Functional Performance measured by Fugl-Meyer Assessment Scale.	4 weeks
measured by EMG.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

National Institute for Locomotor Disabilities (Divyangjan); 🇮🇳 Kolkata, WEST BENGAL, India

National Institute for Locomotor Disabilities (Divyangjan)

🇮🇳Kolkata, WEST BENGAL, India

Dr Sourov Saha

Principal investigator

9433845886

sourov.saha.pht@gmail.com