Stroke, IschemicNCT05945966
Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients
A study testing Unilateral training group (UTG) and Bilateral training group (BTG). in people with Stroke, Ischemic and Balance; Distorted, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic
- What is being tested?
- Unilateral training group (UTG) and Bilateral training group (BTG).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 15 Sep 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable patients (the diagnosis was made by neurologist).
- Cognitive level is greater than 25 on MMSE.
- Chronic stroke Patients (ischemic and hemorrhagic) (6 months to 2 years).
Who cannot join
- Transient ischemic attack.
- Patients with other neurological condition, orthopedic problems, and uncontrolled metabolic disease.
- Severe hearing and visual loss.
- Uncontrolled arterial hypertension.
- Recurrent Stroke.
- Patient diagnosed with brainstem stroke and middle cerebral artery stroke.
- Patient with any cardiovascular unstable condition.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients
Read the detailed description
The aim of this study is to compare the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients. The randomized controlled trial will recruit the stroke patients will be selected and randomly divided into two groups: Group A (unilateral training group (UTG)) and Group B (bilateral training group (BTG)).
Patients in Group A will undergo approach-oriented training using the motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the affected side, while those in Group B underwent strength training for the lower-limb muscles using Delorme's principle for the unaffected side and approach-oriented training using the MRP and PNF for the affected side for a period of six weeks, five days per week. A strengthening regimen will designed for the unaffected side, considering the frequency, intensity, time, and type (FITTs) principle provided by the American College of Sports Medicine (ACSM). The static and dynamic balance along with gait parameters will measure using the functional reach test (FRT), one-leg stance test (OLST), Berg balance scale (BBS) Dynamic Gait Index (DGI), gait parameters (stride length, gait velocity, and cadence), and Brunnstrom recovery stages (BRS) at the baseline and post rehabilitation.
- Conditions
- Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic
- Being tested
- Unilateral training group (UTG), Bilateral training group (BTG).
- Keywords
- Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic
- Medical subject headings
- Ischemic Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral training group (UTG)Other
stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side
Bilateral training group (BTG).Other
stroke patients will be undergone strength training using frequency, intensity, type, time (FITT) principle to non-hemi-paretic side and task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) to hemi-paretic side
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In this group stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side Receives: Other: Unilateral training group (UTG) |
| control group | Active comparator | In this group stroke patients will be undergone strength training using frequency, intensity, type, time (FITT) principle to non-hemi-paretic side and task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) to hemi-paretic side Receives: Other: Bilateral training group (BTG). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional reach test (FRT):
Functional reach test (FRT):
It is clinical outcome measure tool for ascertaining dynamic balance in one task. It is performed with the participants in standing. It is the measure of the difference, in centimeters, between arm's length with arm at 90 degree flexion and maximum forward reach using a fixed base of support. It has 100% reliability and 76% sensitivity
Measured: 9 months
Dynamic gait index (DGI):
Dynamic gait index (DGI):
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls. It has high validity and reliability.
Measured: 9 months
Berg balance scale (BBS):
Berg balance scale (BBS):
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. Its reliability is 0.98
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Nov 2022
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Model description
- patients will be allocated to intervention groups by randomization Patients in group A will be given MRP and PNF techniques to involve side Patients In group B will be given exercises same as above but on unaffected side.The strengthening exercises also given to this group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeest Hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945966
- Sponsor's protocol ID
- REC/RCR & AHS/23/0210
- Status last verified
- Oct 2023
- First submitted
- 7 Jul 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CY, Miyoshi S, Chen CH, Lee KC, Chang LC, Chung JH, Shi HY. Walking ability and functional status after post-acute care for stroke rehabilitation in different age groups: a prospective study based on propensity score matching. Aging (Albany NY). 2020 Jun 1;12(11):10704-10714. doi: 10.18632/aging.103288. Epub 2020 Jun 1.
PubMed 32482912Stoykov ME, Heidle C, Kang S, Lodesky L, Maccary LE, Madhavan S. Sensory-Based Priming for Upper Extremity Hemiparesis After Stroke: A Scoping Review. OTJR (Thorofare N J). 2022 Jan;42(1):65-78. doi: 10.1177/15394492211032606. Epub 2021 Jul 26.
PubMed 34311607Park C, Son H, Yeo B. The effects of lower extremity cross-training on gait and balance in stroke patients: a double-blinded randomized controlled trial. Eur J Phys Rehabil Med. 2021 Feb;57(1):4-12. doi: 10.23736/S1973-9087.20.06183-3. Epub 2020 Sep 6.
PubMed 32891079
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients
- ClinicalTrials.gov ID
- NCT05945966
- Acronym / sponsor ID
- REC/RCR & AHS/23/0210
- Conditions
- Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic
- Keywords
- Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 14 Jul 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 effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients
Detailed description
The aim of this study is to compare the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients. The randomized controlled trial will recruit the stroke patients will be selected and randomly divided into two groups: Group A (unilateral training group (UTG)) and Group B (bilateral training group (BTG)).
Patients in Group A will undergo approach-oriented training using the motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the affected side, while those in Group B underwent strength training for the lower-limb muscles using Delorme's principle for the unaffected side and approach-oriented training using the MRP and PNF for the affected side for a period of six weeks, five days per week. A strengthening regimen will designed for the unaffected side, considering the frequency, intensity, time, and type (FITTs) principle provided by the American College of Sports Medicine (ACSM). The static and dynamic balance along with gait parameters will measure using the functional reach test (FRT), one-leg stance test (OLST), Berg balance scale (BBS) Dynamic Gait Index (DGI), gait parameters (stride length, gait velocity, and cadence), and Brunnstrom recovery stages (BRS) at the baseline and post rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients will be allocated to intervention groups by randomization Patients in group A will be given MRP and PNF techniques to involve side Patients In group B will be given exercises same as above but on unaffected side.The strengthening exercises also given to this group
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Unilateral training group (UTG)In this group stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side |
| control group | Active comparator | Other: Bilateral training group (BTG).In this group stroke patients will be undergone strength training using frequency, intensity, type, time (FITT) principle to non-hemi-paretic side and task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) to hemi-paretic side |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically stable patients (the diagnosis was made by neurologist).
- Cognitive level is greater than 25 on MMSE.
- Chronic stroke Patients (ischemic and hemorrhagic) (6 months to 2 years).
Key exclusion criteria (7 listed)
- Transient ischemic attack.
- Patients with other neurological condition, orthopedic problems, and uncontrolled metabolic disease.
- Severe hearing and visual loss.
- Uncontrolled arterial hypertension.
- Recurrent Stroke.
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 |
|---|---|---|
| Unilateral training group (UTG)stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side | Other | experimental group |
| Bilateral training group (BTG).stroke patients will be undergone strength training using frequency, intensity, type, time (FITT) principle to non-hemi-paretic side and task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) to hemi-paretic side | Other | control group |
Primary outcome
Functional reach test (FRT):
Time frame: 9 months
Functional reach test (FRT): It is clinical outcome measure tool for ascertaining dynamic balance in one task. It is performed with the participants in standing. It is the measure of the difference, in centimeters, between arm's length with arm at 90 degree flexion and maximum forward reach using a fixed base of support. It has 100% reliability and 76% sensitivity
Dynamic gait index (DGI):
Time frame: 9 months
Dynamic gait index (DGI): The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls. It has high validity and reliability.
Berg balance scale (BBS):
Time frame: 9 months
Berg balance scale (BBS): The Berg Balance Scale (BBS) is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. Its reliability is 0.98
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 12 Oct 2023.
- Background: PubMed 32482912Wang CY, Miyoshi S, Chen CH, Lee KC, Chang LC, Chung JH, Shi HY. Walking ability and functional status after post-acute care for stroke rehabilitation in different age groups: a prospective study based on propensity score matching. Aging (Albany NY). 2020 Jun 1;12(11):10704-10714. doi: 10.18632/aging.103288. Epub 2020 Jun 1.
- Background: PubMed 34311607Stoykov ME, Heidle C, Kang S, Lodesky L, Maccary LE, Madhavan S. Sensory-Based Priming for Upper Extremity Hemiparesis After Stroke: A Scoping Review. OTJR (Thorofare N J). 2022 Jan;42(1):65-78. doi: 10.1177/15394492211032606. Epub 2021 Jul 26.
- Background: PubMed 32891079Park C, Son H, Yeo B. The effects of lower extremity cross-training on gait and balance in stroke patients: a double-blinded randomized controlled trial. Eur J Phys Rehabil Med. 2021 Feb;57(1):4-12. doi: 10.23736/S1973-9087.20.06183-3. Epub 2020 Sep 6.
- 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.
Zeest Hashmi, MSNMPT 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 Unilateral training group (UTG) and Bilateral training group (BTG). in people with Stroke, Ischemic and Balance; Distorted, 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 3 inclusion and 7 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 12 Oct 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?
Functional reach test (FRT): (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT05945966, which also lists 3 linked publications.
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 12 Oct 2023.