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NCT Number: NCT06686303

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

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Key information

Conditions

Subacute Stroke

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Bone and Joint Hospital

Sialkot, Punjab Province, 51310, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High frequency Segmental Vibrator

Other

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

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

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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.

  7. 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)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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