NCT07578818

Brief Summary

The aim of this study is to determine the effects of corrective exercises with rhythmic auditory stimulation on balance, motor performance, gait and quality of life in patients with stroke.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress24%
May 2026Aug 2026

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Corrective ExercisesRhythmic Auditory Stimulation (RAS)BalanceMotor performanceGaitQuality of life (QoL)Stroke

Outcome Measures

Primary Outcomes (4)

  • Tinetti POMA test

    The Tinetti POMA test assesses functional mobility, balance, and gait abnormalities with a maximum score of 28. Scores are interpreted as follows: 25-28 (low fall risk), 19-24 (medium fall risk), and below 19 (high fall risk). The test has excellent reliability and requires minimal equipment, taking 10-15 minutes to administer.

    Baseline and 8th week

  • Timed Up & Go test (TUG)

    Timed Up \& Go test: The TUG test assesses functional mobility and balance by measuring the time to stand, walk 3 meters, return, and sit. Scoring interpretation: \<10 seconds (complete independence), \<20 seconds (independence for main transfers), and \>30 seconds (requires assistance). A cut-off score of ≥13.5 seconds predicts fall risk.

    Baseline and 8th week

  • The 6-minute walking test

    The 6-minute walking test: The 6-minute walking test (6MWT) assesses mobility and endurance by measuring the distance covered while walking at one's own pace for 6 minutes. Higher scores indicate better performance. Cut-off scores of 304 meters and 288 meters have been established for walking independence and community ambulation, respectively

    Baseline and 8th week

  • The SF-36v2 health survey short form

    The SF-36v2 health survey short form: The SF-36v2 health survey assesses quality of life through 8 subscales, grouped into physical and mental health categories. Scores range from 0-100, with higher scores indicating better health and quality of life.

    Baseline and 8th week

Study Arms (2)

Standard corrective exercises

ACTIVE COMPARATOR

Standard corrective exercises with conservative treatment.

Other: Standard corrective exercises

Rhythmic auditory stimulation

EXPERIMENTAL

Rhythmic auditory stimulation protocol along with the corrective exercises.

Other: Rhythmic auditory stimulation

Interventions

The experimental group will be given the rhythmic auditory stimulation protocol along with the corrective exercises. 3 sessions per week for 6-8 weeks, 60 minutes per session: 15-min rhythmic warm-up, 30-min RAS main segment along with corrective exercises, 15-min relaxation. A total of 18-24 sessions will be given, each consisting of 60 mins. Weeks 1-2 consisted of RAS-guided gait drills, including tandem walking, military march, and walking on toes and heels, performed for 3 sets of 5-20 steps. In weeks 3-4, participants performed standing with a reduced base of support and RAS leg raises in forward, backward, and sideways directions for 3 sets of 5-10 repetitions. Weeks 5-6 advanced to RAS leg raises in all directions for each leg and graded reaching exercises while standing, each for 3 sets of 5-10 repetitions During weeks 7-8, the program included heel raises and RAS stepping/walking drills in forward, backward, sideways, and tandem directions, completed for 3 sets of 5-20 steps.

Rhythmic auditory stimulation

Corrective exercises: 3 sessions per week for 6-8 weeks, 60 minutes per session: a 15-min warm-up, a 30-min main segment, and a 15-min cool-down. A total of 18-24 sessions will be given, each consisting of 60 mins. In weeks 1-2, participants performed balance-focused tasks including heel-toe walking, tandem standing, and single-leg standing for 3 sets of 2-10 repetitions. During weeks 3-4, the focus shifted to lower limb strength and functional mobility with sit-to-stand training, step-ups, and semi-squats, each performed for 3 sets of 5-10 repetitions. In weeks 5-6, static and dynamic marching were introduced alongside posture correction holds and neck extension exercises, completed for 3 sets of 5-10 reps or 10-30 second holds. Weeks 7-8 emphasized core strengthening through cat stretch, plank, V-shape movement, and Swiss ball bridge exercises, performed for 3 sets of 5-10 repetitions or 10-30 second holds.

Standard corrective exercises

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 40-60 years old.
  • Both male and female.
  • Patients with subacute ischemic stroke (hemiplegia).
  • They had no history of back pain or any special injury.
  • Diagnosis of a first-time stroke or without a sequel of a previous stroke.
  • Hemiparesis with gait disturbance, Tinetti score \< 23 after the stroke.
  • Older adults with hyperkyphosis.

You may not qualify if:

  • Unwillingness to cooperate.
  • Injury during exercise or training period.
  • Absence in at least 3 sessions of training.
  • Independent walkers.
  • Moderate to severe cognitive disorder.
  • Participants with significant orthopedic or chronic pain conditions affecting gait performance.
  • Any other neurologic condition.
  • Visual, hearing, verbal, and cognitive deficits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehab Centre and University of Lahore UOL

Lahore, Punjab Province, 54120, Pakistan

Location

Related Publications (7)

  • Gonzalez-Hoelling S, Bertran-Noguer C, Reig-Garcia G, Suner-Soler R. Effects of a Music-Based Rhythmic Auditory Stimulation on Gait and Balance in Subacute Stroke. Int J Environ Res Public Health. 2021 Feb 19;18(4):2032. doi: 10.3390/ijerph18042032.

    PMID: 33669715BACKGROUND
  • <VARZESH7024581669062600.pdf>.

    BACKGROUND
  • Gonzalez-Hoelling S, Reig-Garcia G, Bertran-Noguer C, Suner-Soler R. The Effect of Music-Based Rhythmic Auditory Stimulation on Balance and Functional Outcomes after Stroke. Healthcare (Basel). 2022 May 12;10(5):899. doi: 10.3390/healthcare10050899.

    PMID: 35628037BACKGROUND
  • <iranfar،+{$userGroup}،+2+37613.pdf>.

    BACKGROUND
  • Park J, Kim T. Effects of Walking Training according to Rhythmic Auditory Stimulation Speed Control Balance of Stroke Patients. The Journal of Korean Physical Therapy. 2023;35(6):213-9.

    BACKGROUND
  • Osundiya O, Joseph O, Olawale O. Effect of overground gait training with rhythmic auditory stimulation on lower limb motor coordination and activities of daily living in stroke survivors: A cross-sectional study. Journal of Clinical Sciences. 2023;20(3).

    BACKGROUND
  • Tarkhasi A, Hadadnezhad M, Sadeghi H. The effect of corrective exercises with massage on balance, motor performance, gait, and quality of life in elderly males with hyperkyphosis: Randomized control trials. Geriatr Nurs. 2025 Jan-Feb;61:169-176. doi: 10.1016/j.gerinurse.2024.11.002. Epub 2024 Nov 16.

    PMID: 39550789BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hira Jabeen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

May 5, 2026

First Posted

May 11, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations