Effects of Combined Segmental Vibrator and Neuromuscular Electrical Stimulation in Subacute Stroke

NCT ID: NCT06686303

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-05

Brief Summary

Stroke is leading cause of death and disability worldwide, resulting in significant functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb. There is a need for more effective interventions targeting upper limb sensory motor impairments. The aim of this study is to study combined effect of segmental vibrator and neuromuscular electrical stimulation for flexor and extensor muscle groups on upper limb function in sub-acute stroke.

Detailed Description

This study will be a randomized clinical trial and will be conducted in physiotherapy department of Allama Iqbal Memorial Teaching Hospital Sialkot, National Bone and Joint Hospital and Bashir Hospital Sialkot. Forty stroke patients will be recruited through non-probability convenience sampling technique and will be randomly divided in two equal groups Group A and group B through lottery method. Group A will receive high frequency segmental vibration on flexor and extensor muscle groups while group B will receive neuromuscular electrical stimulation along with high frequency segmental vibration(100Hz) on flexor and extensor muscle groups Data will be collected from patients of sub-acute stroke by using screening tool MoCA(for cognition) and assessment tools Fugl-Meyer Assessment Scale(for upper limb function), Wolf Motor Functional Test(for motor function), Modified Ashworth Scale(for spasticity) , Barthel Index(for ADLs), Maximal Hand Grip Strength(for manual dexterity), Maximal Pinch Grip(for manual dexterity), Nottingham Sensory Assessment(for somatosensory function). An informed consent will be taken. Outcome measures will be assessed at baseline, at 4th week and at 8th week. Follow up will be performed at 12th week. Data analysis will be done by SPSS version 28.0.

Conditions

Subacute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group A received the high frequency segmental vibrator.

Group Type: EXPERIMENTAL

High frequency Segmental Vibrator

Intervention Type: OTHER

Segmental vibrations of high frequency was used on each flexor and extensor interspersed with a 1 minute break.

Group B

Group B received the combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.

Group Type: EXPERIMENTAL

Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.

Intervention Type: OTHER

Segmental vibrations of high frequency with Neuromuscular Electrical Stimulation was given on each flexor and extensor.

Interventions

High frequency Segmental Vibrator

Segmental vibrations of high frequency was used on each flexor and extensor interspersed with a 1 minute break.

Intervention Type: OTHER

Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.

Segmental vibrations of high frequency with Neuromuscular Electrical Stimulation was given on each flexor and extensor.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of both genders
• Aged between 45 and 65 years old
• First ever ischemic stroke experienced more than 3 months before the enrollment
• Spasticity of spastic agonist muscles ranging from 0-2 on the MAS

Exclusion Criteria

• Patients with bilateral brain lesions
• Ischemic involvement of cerebellum or basal ganglia
• Psychiatric disease and cognitive impairment
• Previous history of other neurological diseases,rheumatic and orthopaedic conditions
• Patients under anti-spastic therapy or other clinical trials
• Metal implants e.g. cardiac pacemakers

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

National Bone and Joint Hospital

Sialkot, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/0216 RabiaSaleem

Identifier Type: -

Identifier Source: org_study_id