StrokeNCT05751161
Effect of Gait Training With Auditory Stimuli on Balance, Gait & Funtional Independence in Stroke
A study testing conventional gait training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- conventional gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dependent gait
- Aphasia
- Any hearing or visual defects
- Moderate to severe cognitive disorder
- People not willing to participtae
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan society for the rehabilitation of disabled
Lahore, Punjab Province, 52544
About this study
Official title: Effect of Gait Training With Auditory Stimuli on Dynamic Balance, Gait and Functional Independence in Chronic Stroke
To determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke.
Read the detailed description
The purpose of this study is to find the effect of gait training with auditory stimuli using a smart phone metronome application on dynamic balance, gait and functional abilities of chronic stroke patients.
- Conditions
- Stroke
- Being tested
- conventional gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional gait trainingOther
Also called Gait training with auditory stimuli
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: conventional gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
Barthel index
it is an ordinal scale that measures functional independence in the domain of personal care and mobility.
Measured: 6 weeks
Gait speed
it is the time one takes to walk a specific distance on level surface over a short distance. A distance of 3 to 10 meters is measured over a level surface with 2 meters acceleration and 2 meter for decleration
Measured: 6 weeks
POMA
It evaluates dynamic balance and walking patters.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start11 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria samad, Principal investigator, Riphah International Universityfatima tariq, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751161
- Sponsor's protocol ID
- REC/RCR & AHS/22/0211
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28744049
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gait Training With Auditory Stimuli on Dynamic Balance, Gait and Functional Independence in Chronic Stroke
- ClinicalTrials.gov ID
- NCT05751161
- Acronym / sponsor ID
- REC/RCR & AHS/22/0211
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke.
Detailed description
The purpose of this study is to find the effect of gait training with auditory stimuli using a smart phone metronome application on dynamic balance, gait and functional abilities of chronic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| effect of gait training with AS on dynamic balance, gait and functional independence in stroke | Experimental | Other: conventional gait trainingPatients with chronic stroke receive gait training with auditory stimuli to improve dynamic balance, gait and functional independence. |
| effect of conventional gait training on dynamic balance, gait and functional independence in stroke | Other | Other: conventional gait trainingPatients 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Dependent gait
- Aphasia
- Any hearing or visual defects
- Moderate to severe cognitive disorder
- People not willing to participtae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional gait trainingAlso: Gait training with auditory stimuliThe 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. | Other | effect of conventional gait training on dynamic balance, gait and functional independence in stroke, effect of gait training with AS on dynamic balance, gait and functional independence in stroke |
Primary outcome
Berg balance scale
Time frame: 6 weeks
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.
3 secondary outcomes
Barthel index
Time frame: 6 weeks
Gait speed
Time frame: 6 weeks
POMA
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 28744049Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maria samad principal investigator
Riphah International University
fatima tariq principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional gait training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg balance scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05751161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.