NCT07629882

Brief Summary

This study will compare the effects of Functional Electrical Stimulation (FES) and Whole Body Vibration Training (WBVT) on lower limb motor control, balance, and physical performance in post-stroke patients. It will be a single-blinded randomized clinical trial including 34 participants, who will be allocated into two groups. Both groups will receive their respective interventions 4 days per week for 8 weeks. Outcomes will be assessed at baseline and after 8 weeks using the Fugl-Meyer Assessment for lower extremity motor control, Berg Balance Scale for balance, and Barthel Index for physical performance.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Jun 2025Aug 2026

Study Start

First participant enrolled

June 5, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2026

Expected
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Functional Electrical Stimulation (FES)Stroke RehabilitationPhysical PerformanceBalanceLower Limb Motor ControlWhole Body Vibration Training (WBVT)

Outcome Measures

Primary Outcomes (1)

  • lower Limb Motor Control

    Assessed using the Fugl-Meyer Assessment for Lower Extremity.

    Baseline and 8 weeks post-intervention

Secondary Outcomes (2)

  • Balance

    Baseline and 8 weeks post-intervention

  • Physical Performance

    Baseline and 8 weeks post-intervention

Study Arms (2)

Functional Electrical Stimulation Group

EXPERIMENTAL

Participants in this arm will receive transcutaneous Functional Electrical Stimulation for lower limb rehabilitation for 8 weeks. Stimulation will be applied to selected lower limb muscles including tibialis anterior, quadriceps, hamstrings, and peroneal muscles. Treatment parameters will progress according to tolerance, including intensity, session duration, and functional movement integration. Outcomes will be assessed at baseline and after 8 weeks.

Device: Functional Electrical Stimulation

Whole Body Vibration Training Group

ACTIVE COMPARATOR

Participants in this arm will receive Whole Body Vibration Training using a vibration platform for 8 weeks. Training will include progressive activities such as standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance. Vibration frequency, duration, and exercise difficulty will be gradually progressed according to tolerance. Outcomes will be assessed at baseline and after 8 weeks. After this, go to Interventions and add Functional Electrical Stimulation and Whole Body Vibration Training, then assign each intervention to its matching arm.

Device: Whole Body Vibration Training

Interventions

Functional Electrical Stimulation will be delivered transcutaneously to selected lower limb muscles for 8 weeks. Stimulation will target tibialis anterior, quadriceps, hamstrings, peroneal muscles, and other lower limb muscles according to patient need and tolerance. The intervention will use biphasic symmetrical pulsed current with progressive intensity, duration, and functional movement integration. Treatment will be supervised by a physiotherapist, and outcomes will be assessed at baseline and after 8 weeks.

Also known as: FES, Neuromuscular Electrical Stimulation, Electrical Stimulation Therapy
Functional Electrical Stimulation Group

Whole Body Vibration Training will be delivered using a vibration platform for 8 weeks. Participants will perform progressive lower limb activities including standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance exercises. Frequency, duration, and difficulty will be progressed according to patient tolerance under physiotherapist supervision.

Also known as: Whole Body Vibration, WBV Training
Whole Body Vibration Training Group

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the patient is between the ages of 35 and 70.
  • Both male and female participants will be included.
  • Chronic post-stroke patients from 6 months to 1 year.
  • Stroke patients who have a neurological impairment.
  • Individuals who experienced a single stroke in either the left or right hemisphere of the brain.
  • Lower limb motor impairment with Fugl-Meyer Lower Extremity Score ≤ 28.
  • Barthel Index Score ≥ 60.
  • Berg Balance Scale Score ≥ 21.

You may not qualify if:

  • patients suffering from unstable cardiac condition, severe hypertension, congestive heart failure, aphasia, or cognitive impairments for which exercises are contraindicated.
  • Patients with recurrent stroke.
  • Patients undergoing other form of lower limb stimulation therapy concurrently.
  • Severe orthopedic conditions or joint deformities affecting lower limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafiz Physiotherapy Center

Gujrat, Punjab Province, 50700, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ambreen Iqbal IQBAL

    Riphah International University Role

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A single-blinded design will be implemented: the outcome assessor will remain blinded to group allocation to minimize measurement bias and enhance the reliability of results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated into two equal groups: Functional Electrical Stimulation group and Whole Body Vibration Training group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

June 5, 2025

Primary Completion

July 6, 2026

Study Completion (Estimated)

August 6, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

The individual participant data sharing plan has not yet been finalized.

Locations