Chronic Stroke PatientsNCT06696950
Multimodal Gait Training With and Without Rhythmic Auditory Stimulation in Chronic Stroke Patients
A study testing Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation and Multimodal gait training in people with Chronic Stroke Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
The primary goal of this randomized clinical trial is to investigate the efficacy of multimodal gait training, with and without rhythmic auditory stimulation, in improving gait, coordination and reducing fall risk in individuals with chronic stroke This clinical trial features two distinct groups 42 participants were… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Chronic Stroke Patients
- What is being tested?
- Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation and Multimodal gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2024to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of age between 45 and 70 year
- Participants of both genders were included.
- Participants who were able to walk independently indoors without walking aid
- Participants were included if they had lower limb motor impairment (Fugl-Meyer Assessment lower extremity (FMLE) score less than score less than 34
- Participants with stroke lasting longer than six months
- Participants with Mini-Mental Status Examination score 24 or more than 24
Show all 9Show fewer
- Participants with the capability to keep in sitting position for 30 minutes
- Participants with the history of fall in the past year
- Participants with no visual or auditory impairments that would interfere with the training
Who cannot join
- Participants with respiratory problems.
- Participants with any orthopedic condition.
- Participants with aphasia that impeded communication.
- Participants with have severe cardiac disease.
- Participants with resistant hypertension despite use of medication (average systolic blood pressure ≥ 140 mmHg or average diastolic blood pressure ≥ 90 mmHg measured over 7 days)
- Participants with presence of non-healing ulcers in the lower limbs, and osteoporosis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Memorial Hospital, Islam teaching hospital, National Bone joint Hospital, Amra Medical Center
Sialkot, Punjab Province, 51040
About this study
Official title: Effects of Multimodal Gait Training With and Without Rhythmic Auditory Stimulation on Coordination, Gait and Risk of Fall in Chronic Stroke Patients
The primary goal of this randomized clinical trial is to investigate the efficacy of multimodal gait training, with and without rhythmic auditory stimulation, in improving gait, coordination and reducing fall risk in individuals with chronic stroke This clinical trial features two distinct groups 42 participants were randomly divided into two groups of 21. Group A will receive Multimodal gait training along with rhythmic auditory stimulation while Group B will receive only multimodal gait training
Participants will:
- Take 12 sessions of the MMGT program over six weeks
- With each session lasting 45 minutes, including 10-minute rest breaks.
- Conditions
- Chronic Stroke Patients
- Being tested
- Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation, Multimodal gait training
- Keywords
- Chronic Stroke, Gate Training, Multimodal, Rhythmic auditory stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulationOther
Unilateral step training, inclined treadmill training, over ground training, repetitive isochronous pulses via metronome
Multimodal gait trainingOther
Unilateral step training, inclined treadmill training, over ground training,
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received Multimodal gait training with Rhythmic auditory stimulation Receives: Other: Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation |
| Group B | Experimental | Group B Multimodal Gait training without rhythmic auditory stimulation Receives: Other: Multimodal gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT)
The Lower Extremity Motor Coordination test (LEMCOT) is a clinically useful performance-based test to assess coordination improvements of lower limb in post-stroke individuals
Measured: 6 weeks
Dynamic gait index (DGI)
The dynamic gait index is a comprehensive clinical assessment performance based tool used designed to evaluate gait-related task such as dynamic balance, gait and risk of fall in older adults with various neurological conditions
Measured: 6 weeks
Fall Efficacy Scale-International (FES-I)
Fall efficacy scale-international (FES- I) is a standardized, short and easy to administer tool evaluates fear of falling and measures concerns about falling
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 posted20 Nov 2024
- Study start10 Jan 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke PatientsStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binish Afzal, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696950
- Sponsor's protocol ID
- REC/RCR&AHS/24/0202
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Gait Training With and Without Rhythmic Auditory Stimulation on Coordination, Gait and Risk of Fall in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06696950
- Acronym / sponsor ID
- REC/RCR&AHS/24/0202
- Conditions
- Chronic Stroke Patients
- Keywords
- Chronic Stroke, Gate Training, Multimodal, Rhythmic auditory stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 20 Nov 2024 (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.
The primary goal of this randomized clinical trial is to investigate the efficacy of multimodal gait training, with and without rhythmic auditory stimulation, in improving gait, coordination and reducing fall risk in individuals with chronic stroke This clinical trial features two distinct groups 42 participants were randomly divided into two groups of 21. Group A will receive Multimodal gait training along with rhythmic auditory stimulation while Group B will receive only multimodal gait training
Participants will:
- Take 12 sessions of the MMGT program over six weeks
- With each session lasting 45 minutes, including 10-minute rest breaks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulationGroup A received Multimodal gait training with Rhythmic auditory stimulation |
| Group B | Experimental | Other: Multimodal gait trainingGroup B Multimodal Gait training without rhythmic auditory stimulation |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants of age between 45 and 70 year
- Participants of both genders were included.
- Participants who were able to walk independently indoors without walking aid
- Participants were included if they had lower limb motor impairment (Fugl-Meyer Assessment lower extremity (FMLE) score less than score less than 34
- Participants with stroke lasting longer than six months
Key exclusion criteria (6 listed)
- Participants with respiratory problems.
- Participants with any orthopedic condition.
- Participants with aphasia that impeded communication.
- Participants with have severe cardiac disease.
- Participants with resistant hypertension despite use of medication (average systolic blood pressure ≥ 140 mmHg or average diastolic blood pressure ≥ 90 mmHg measured over 7 days)
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 |
|---|---|---|
| Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulationUnilateral step training, inclined treadmill training, over ground training, repetitive isochronous pulses via metronome | Other | Group A |
| Multimodal gait trainingUnilateral step training, inclined treadmill training, over ground training, | Other | Group B |
Primary outcome
LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT)
Time frame: 6 weeks
The Lower Extremity Motor Coordination test (LEMCOT) is a clinically useful performance-based test to assess coordination improvements of lower limb in post-stroke individuals
Dynamic gait index (DGI)
Time frame: 6 weeks
The dynamic gait index is a comprehensive clinical assessment performance based tool used designed to evaluate gait-related task such as dynamic balance, gait and risk of fall in older adults with various neurological conditions
Fall Efficacy Scale-International (FES-I)
Time frame: 6 weeks
Fall efficacy scale-international (FES- I) is a standardized, short and easy to administer tool evaluates fear of falling and measures concerns about falling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Stroke Patients
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Lumbar Spinal Manipulation in Stroke
Stroke
Active, not recruiting
RESPARK - Brain Q for Chronic Stroke
Stroke, Chronic Stroke Patients
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.
Binish Afzal, MS-NMPT 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 Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation and Multimodal gait training in people with Chronic Stroke Patients, 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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2024.