NCT05356481

Brief Summary

The aim of this study is to observe and to compare effects of segmental vibration on flexors versus extensor muscle groups on upper limb function in post-stroke patients. This study will be helpful in finding out that either low frequency segmental vibration on flexors muscle group is better in improving upper limb function or low frequency segmental vibration on extensor muscle group is more beneficent in improving upper limb function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

April 28, 2022

Last Update Submit

September 14, 2023

Conditions

Stroke

Keywords

segmental muscle vibration,spasticity,upper limb function

Outcome Measures

Primary Outcomes (5)

  • Wolf Motor Functional Test

    WMFT is valid and reliable on assessing upper extremities motor function of stroke patients. The WFMT is a tool with high interrater reliability, internal consistency, test-retest reliability and adequate stability.

    10 to 15 minutes

  • Modified Ashworth Scale

    This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity

    4 to 5 minutes

  • Fugl Meyer Assessment

    Fugl Meyer Assessment

    10 minutes

  • Manual Muscle Testing

    to check muscle strength

    8 to 10 minutes

  • • Brunnstrom Stages of Stroke Recovery • Brunnstrom Stages of Stroke Recovery Brunnstrom Stages of Stroke Recovery

    to check the stages of improvemnet

    5 to 10 minutes

Study Arms (2)

Experimental Group A

EXPERIMENTAL

will recieve (low frequency segmental muscle vibration of 41 Hz over flexors muscles of upper limb Pectoralis minor, Biceps brachii, Flexor carpi muscle + general physical therapy session ) The transducer applied perpendicular to the muscle near its distal tendon insertion.The application consisted of 3 vibration sessions each with duration of 5 minutes for each muscle with 1 minute interval separated these sessions during the interval muscle vibration will interrupted and the subject will request to relax the muscle

Device: segmental muscle vibration

Experimental Group B

EXPERIMENTAL

group receive (low frequency segmental muscle vibration of 41 Hz over extensors muscles of upper limb Triceps brachii, Extensor carpi radialis longus \& brevis + general physical therapy session ) The transducer applied perpendicular to the muscle near its distal tendon insertion The application consisted of 3 vibration sessions each with duration of 5 minutes for each muscle with 1 minute interval separated these sessions during the interval muscle vibration will interrupted and the subject will request to relax the muscle

Device: segmental muscle vibration

Interventions

segmental muscle vibrationDEVICE

Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session

Also known as: general physical therapy session
Experimental Group AExperimental Group B

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders
  • Age: between 50-65 years.
  • Spasticity 1-3 on MAS
  • months post stroke patients

You may not qualify if:

  • Cardiovascular event (myocardial ischemia or infarction) occurring within 12 months,
  • Use of any antispastic drug
  • Pain from vibration
  • Inflammatory osteoarticular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Muhammad shahid shabbir

Rawalpindi, Punjab Province, Pakistan

Location

Riphah International University

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (1)

  • Shabbir MS, Saeed A, Tariq S, Shabbir N, Nasir R, Riaz H. Effects of segmental muscle vibration on flexor and extensor groups of the upper limb in enhancing functional recovery after stroke: A randomized trial. J Bodyw Mov Ther. 2025 Dec;45:1-7. doi: 10.1016/j.jbmt.2025.07.019. Epub 2025 Jul 25.

    PMID: 41316550DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, PhD*

    Riphah international university.pakistan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 2, 2022

Study Start

January 15, 2023

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)