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

R

Riphah International University

Status

Completed

Conditions

Subacute Stroke

Treatments

Other: Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.
Other: High frequency Segmental Vibrator

Study type

Interventional

Funder types

Other

Identifiers

NCT06686303
REC/0216 RabiaSaleem

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Group A
Experimental group
Description:
Group A received the high frequency segmental vibrator.
Treatment:
Other: High frequency Segmental Vibrator
Group B
Experimental group
Description:
Group B received the combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.
Treatment:
Other: Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.

Trial contacts and locations

1

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Central trial contact

Imran Amjad, PHD

Data sourced from clinicaltrials.gov

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