NCT07554794

Brief Summary

A 4-week program of vibration training in a seated position combined with conventional rehabilitation led to significant improvements in unaffected side lower limb muscle strength, functional recovery, quality of life, and self-esteem in patients with chronic stroke. No significant improvement was noted in affected side lower limb muscle strength. These findings highlight the integration of localized muscle vibration training into rehabilitation as a promising strategy for treating individuals with chronic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 18, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

January 12, 2026

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • muscle strength measured by manual muscle test

    From enrollment to the end of treatment at 4 weeks

  • functional recovery measured by Barthel index

    From enrollment to the end of treatment at 4 weeks

  • functional recovery measured by Stroke Impact Scale

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (2)

  • quality of life measured by short form 12 health survey

    From enrollment to the end of treatment at 4 weeks

  • self-esteem measured by Rosenberg Self-Esteem Scale

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

patients with chronic stroke underwent conventional rehabilitation plus vibration training

EXPERIMENTAL
Device: vibration training

patients with chronic stroke underwent conventional rehabilitation

NO INTERVENTION

Interventions

seated vibration training

patients with chronic stroke underwent conventional rehabilitation plus vibration training

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hospitalization for chronic stroke (≥ 6 months since onset)
  • age ≥ 20 years
  • Mini-Mental State Examination score ≥ 24
  • able to communicate verbally or nonverbally and understand Mandarin or Taiwanese
  • modified Rankin Scale of 2 to 4
  • Brunnstrom stage ≥ 3
  • willing to participate with consent to randomization

You may not qualify if:

  • transient ischemic attack
  • neuromuscular or musculoskeletal disorders of the both upper or lower limbs or history of orthopedic surgery within the past 6 months
  • deep vein thrombosis
  • pacemaker implantation
  • unstable conditions, including cardiovascular disease, cancer, end-stage renal disease requiring hemodialysis, or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Chair, Department of Nursing, College of Nursing, National Defense Medical University

Study Record Dates

First Submitted

January 12, 2026

First Posted

April 28, 2026

Study Start

April 18, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations