StrokeNCT05834192
Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training Among Stroke Patients
A study testing Backward treadmill walking and Lower extremity cross training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is one of the high rated neurological disorders, induced by disruption of brain's blood flow. Stroke can alter the level of consciousness, motor and cognitive skills, sensory perception and language; it all depends on the extent of injury and the region of brain that is affected. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Backward treadmill walking and Lower extremity cross training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2023to 30 Oct 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic stroke patient diagnosed within last 6 months to 1 year
- Age 55 to 75 years
- Cognition score on Mini-mental state examination > 24
- Able to independently walk 10 m without walking aids
- Able to understand instructions
Who cannot join
- Who will have visual or vestibular injury
- Patients having history of orthopedic surgery or having an orthopedic condition
- Who will have >grade 2 on modified Ashworth Scale (MAS)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Safi teaching hospital Faisalabad
Faisalābad, Punjab Province, 38000
Shahid Shafique, DPT, 03326649539, shahidshafiq777@gmail.com
Touseeq Ahmad, Masters
About this study
Official title: Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training on Gross Motor Function and Balance Among Stroke Patients
Stroke is one of the high rated neurological disorders, induced by disruption of brain's blood flow. Stroke can alter the level of consciousness, motor and cognitive skills, sensory perception and language; it all depends on the extent of injury and the region of brain that is affected. Even though all the rehabilitation given to the "stroke" patients, but still 25-30% of the survivors still have gait and balance problem and they require complete physical support before their discharge from the hospital. Backward treadmill walking has reported numerous benefits in improving balance, motor function and gait. Cross training is a technique which is applied to healthy limb of the individual to increase muscle strength and muscle activity.so the aim of this study is to find the effects of backward treadmill walking and lower extremity cross training on gross motor function and balance among stroke patients.
The study will be randomized clinical trials, Participants will be randomly allocated into two groups each group will have 13. This study will be conducted in Safi teaching Hospital Faisalabad. Group A will be treated with backward treadmill walking and group B will be treated with lower extremity cross training. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. Outcome will be measured before and after giving treatment by using Tinetti performance oriented mobility assessment and lower extremity functional scale. The results will be calculated by using SPSS version 25. Frequencies and mean standard deviation will be measured, parametric and non-parametric tests will be applied
- Conditions
- Stroke
- Being tested
- Backward treadmill walking, Lower extremity cross training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward treadmill walkingOther
Backward Treadmill walking will be given to this group. Speed settings of treadmill will be established based on the previous motor function of participants. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down.
Lower extremity cross trainingOther
For cross-training, a strong resistance will be applied by the therapist until a response will be achieved on the contralateral lower extremity at the end range of motion. Resistance will be consistently applied for 10 seconds once a response will be achieved.
All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down.
| Study group | Role | What they receive |
|---|---|---|
| Backward treadmill walking group | Experimental | Not described Receives: Other: Backward treadmill walking |
| Lower extremity cross training | Active comparator | Not described Receives: Other: Lower extremity cross training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Functional Scale (LEFS)
It consists of 20 questions designed to assess a person's ability to perform everyday tasks, such as getting into or out of the bath, walking between rooms, squatting, and sitting for 1 hour. Performance is rated on a 5-point scale with maximum score of 80. Lower score shows greater disability
Measured: 8 weeks
Tinetti Performance Oriented Mobility Assessment (POMA)
it comprises 16 items (9 balance-related and 7 gait-related items). The highest achievable score being 28 points (16 for balance and 12 for gait). A higher score indicates better balance. A cutoff score greater than 17 points has been associated with fall risk in the older adult population.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start25 Feb 2023
- Primary completion18 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Jabeen, Masters, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834192
- Sponsor's protocol ID
- REC/RCR&AHS/23/0221
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 28 Apr 2023
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training on Gross Motor Function and Balance Among Stroke Patients
- ClinicalTrials.gov ID
- NCT05834192
- Acronym / sponsor ID
- REC/RCR&AHS/23/0221
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 18 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 28 Apr 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.
Stroke is one of the high rated neurological disorders, induced by disruption of brain's blood flow. Stroke can alter the level of consciousness, motor and cognitive skills, sensory perception and language; it all depends on the extent of injury and the region of brain that is affected. Even though all the rehabilitation given to the "stroke" patients, but still 25-30% of the survivors still have gait and balance problem and they require complete physical support before their discharge from the hospital. Backward treadmill walking has reported numerous benefits in improving balance, motor function and gait. Cross training is a technique which is applied to healthy limb of the individual to increase muscle strength and muscle activity.so the aim of this study is to find the effects of backward treadmill walking and lower extremity cross training on gross motor function and balance among stroke patients.
The study will be randomized clinical trials, Participants will be randomly allocated into two groups each group will have 13. This study will be conducted in Safi teaching Hospital Faisalabad. Group A will be treated with backward treadmill walking and group B will be treated with lower extremity cross training. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. Outcome will be measured before and after giving treatment by using Tinetti performance oriented mobility assessment and lower extremity functional scale. The results will be calculated by using SPSS version 25. Frequencies and mean standard deviation will be measured, parametric and non-parametric tests will be applied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Backward treadmill walking group | Experimental | Other: Backward treadmill walking |
| Lower extremity cross training | Active comparator | Other: Lower extremity cross training |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemiplegic stroke patient diagnosed within last 6 months to 1 year
- Age 55 to 75 years
- Cognition score on Mini-mental state examination > 24
- Able to independently walk 10 m without walking aids
- Able to understand instructions
Key exclusion criteria (3 listed)
- Who will have visual or vestibular injury
- Patients having history of orthopedic surgery or having an orthopedic condition
- Who will have >grade 2 on modified Ashworth Scale (MAS)
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 |
|---|---|---|
| Backward treadmill walkingBackward Treadmill walking will be given to this group. Speed settings of treadmill will be established based on the previous motor function of participants. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. | Other | Backward treadmill walking group |
| Lower extremity cross trainingFor cross-training, a strong resistance will be applied by the therapist until a response will be achieved on the contralateral lower extremity at the end range of motion. Resistance will be consistently applied for 10 seconds once a response will be achieved. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. | Other | Lower extremity cross training |
Primary outcome
Lower Extremity Functional Scale (LEFS)
Time frame: 8 weeks
It consists of 20 questions designed to assess a person's ability to perform everyday tasks, such as getting into or out of the bath, walking between rooms, squatting, and sitting for 1 hour. Performance is rated on a 5-point scale with maximum score of 80. Lower score shows greater disability
Tinetti Performance Oriented Mobility Assessment (POMA)
Time frame: 8 weeks
it comprises 16 items (9 balance-related and 7 gait-related items). The highest achievable score being 28 points (16 for balance and 12 for gait). A higher score indicates better balance. A cutoff score greater than 17 points has been associated with fall risk in the older adult population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Hira Jabeen, Masters 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 Backward treadmill walking and Lower extremity cross 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 3 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: status not confirmed, as of the sponsor's last update on 28 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hira Jabeen, Masters (+923234116506, hira.jabeen@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Functional Scale (LEFS) (time frame: 8 weeks). The study lists 2 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 28 Apr 2023.