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

NCT06686303 | Completed

• 1 other identifier: REC/0216 RabiaSaleem
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacute Stroke

Outcome Measures

Primary Outcomes (7)

• MoCA(Montreal Cognitive Assessment)

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Group A

EXPERIMENTAL

Group A received the high frequency segmental vibrator.

Other: High frequency Segmental Vibrator

Group B

EXPERIMENTAL

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.

Interventions

High frequency Segmental Vibrator OTHER

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

Group A

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.

Group B

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

National Bone and Joint Hospital

Sialkot, Punjab Province, 51310, Pakistan

Location

Study Officials

• Aruba Saeed, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: January 1, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)