NCT05751161

Brief Summary

To determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

February 20, 2023

Last Update Submit

March 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Berg balance scale

    To identify the effect of treatment on dynamic balance. The BBS consists of 14 items scored on a 5 point ordinal scale , ramging from 0-4 ..0 means unable to sit without support .4 means able to sit independently.

    6 weeks

Secondary Outcomes (3)

  • Barthel index

    6 weeks

  • Gait speed

    6 weeks

  • POMA

    6 weeks

Study Arms (2)

effect of gait training with AS on dynamic balance, gait and functional independence in stroke

EXPERIMENTAL

Patients with chronic stroke receive gait training with auditory stimuli to improve dynamic balance, gait and functional independence.

Other: conventional gait training

effect of conventional gait training on dynamic balance, gait and functional independence in stroke

OTHER

Patients in this group receive conventional gait training only to improve dynamic balance, gait and functional independence .Patients did not receive auditory stimuli for gait training.

Other: conventional gait training

Interventions

The experimental group received circuit gait training with auditory stimuli using a smartphone metronome application. The training program consisted of eight different activities i.e. tandem walk, one-leg standing, military march, sitting up and forward walk, lateral walk, kicking a ball towards the wall, walking on a set pattern and obstacle walk .Patient will practice each task for 3-4 mints and three times per week.

Also known as: Gait training with auditory stimuli
effect of conventional gait training on dynamic balance, gait and functional independence in strokeeffect of gait training with AS on dynamic balance, gait and functional independence in stroke

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • both gender
  • Age between 30-70
  • More than 6 months after the stroke
  • Able to walk more than 10 meters independently
  • MMSE score of 24

You may not qualify if:

  • Dependent gait
  • Aphasia
  • Any hearing or visual defects
  • Moderate to severe cognitive disorder
  • People not willing to participtae

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan society for the rehabilitation of disabled

Lahore, Punjab Province, 52544, Pakistan

Location

Related Publications (1)

  • Park MH, Won JI. The effects of task-oriented training with altered sensory input on balance in patients with chronic stroke. J Phys Ther Sci. 2017 Jul;29(7):1208-1211. doi: 10.1589/jpts.29.1208. Epub 2017 Jul 15.

    PMID: 28744049BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • maria samad

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • fatima tariq

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

February 11, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations