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

April 7, 2025 updated by: Riphah International University

Combined Effects of Segmental Vibrator With Neuromuscular Electrical Stimulation for Flexor and Extensor Muscle Groups on Upper Limb Function in Sub Acute Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan, 51310
        • National Bone and Joint Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A received the high frequency segmental vibrator.
Other: High frequency Segmental Vibrator
Segmental vibrations of high frequency was used on each flexor and extensor interspersed with a 1 minute break.
Experimental: Group B
Group B received the combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA(Montreal Cognitive Assessment)
Time Frame: Baseline and 8 weeks
MoCA is a screening tool used to evaluate the cognition in stroke patients. Maximum Score 30 Score > 25 considered normal cognition
Baseline and 8 weeks
Fugl-Meyer Assessment
Time Frame: Baseline and 8 weeks
Fugl-Meyer is an assessment tool used to evaluate the upper limb function in stroke patients. Upper Extrimity Maximum Score: 66
Baseline and 8 weeks
Wolf Motor Functional Test
Time Frame: Baseline and 8 weeks
Wolf Motor Functional Test is an assessment tool used to evaluate motor function in stroke patients. The WMFT consists of 15 functional tasks and 2 strength-based tasks (total 17 items). Each task is rated on a 6-point ordinal scale
Baseline and 8 weeks
Barthel Index
Time Frame: Baseline and 8 weeks
BI is an assessment tool used to evaluate ADLs in stroke patients. Minimum Score: 0 (completely dependent) and Maximum Score: 100 (fully independent)
Baseline and 8 weeks
Modified Ashworth Scale
Time Frame: Baseline and 8 weeks
MAS is an assessment tool used to evaluate spasticity in stroke patients. Minimum score 0 and maximum score 4
Baseline and 8 weeks
Maximal Hand and Pinch Grip Strength
Time Frame: Baseline and 8 weeks
Maximal Hand and Pinch Grip Strength is an assessment tool used to evaluate manual dexterity in stroke patients measured by Dynamometer.
Baseline and 8 weeks
Nottingham Sensory Assessment
Time Frame: Baseline and 8 weeks
Nottingham Sensory Assessment is an assessment tool used to evaluate somatosensory sensation in stroke patients. Minimum Score: 0, Maximum Score: 42 (normal sensation)
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Aruba Saeed, MS-NMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 5, 2024

Study Completion (Actual)

December 5, 2024

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/0216 RabiaSaleem

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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