StrokeNCT05097391
Effectiveness of Paretic Lower Limb Loading During Over-ground Training Among Stroke Survivors
A study testing Warm-up (5 minutes), Conventional physiotherapy exercise (15 minutes) and Over-ground training with lower limb loading (15-25 minutes) in people with Stroke and Hemiparesis;Poststroke/CVA, run by Bayero University Kano, Nigeria at 1 site in Nigeria.
Trial summary
Post-stroke gait deviations contribute to significant functional disability, impaired walking ability and poor quality of life. Prior studies suggest that gait training with paretic lower limb loading may improve gait parameters and walking ability in post-stroke. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stroke, Hemiparesis;Poststroke/CVA
- What is being tested?
- Warm-up (5 minutes), Conventional physiotherapy exercise (15 minutes) and Over-ground training with lower limb loading (15-25 minutes)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNigeria
- Study dates
- 2 Aug 2021to 14 Mar 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral ischemic or hemorrhagic stroke occurring at least 3 months before enrolment
- Male or female between the age of 20 and 70 years
- Having a Modified Rankin Scale (MRS) scores of 1, 2, or 3, and also able to walk at least 10 meters independently without an assistive device
- Ability to follow verbal instructions.
Who cannot join
- Cognitive impairments
- Visual impairments
- Musculoskeletal disorders that may affect gait such as arthritis
- Other neurological disorders such as Parkinson's disease, multiple sclerosis
- Cardio-respiratory conditions that may limit participation such as atelectasis
- Concurrent participation in other interventional clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Lower-limb Loading During Over-ground Training on Selected Gait Parameters and Motor Function of Stroke Survivors: A Randomized Controlled Trial
Post-stroke gait deviations contribute to significant functional disability, impaired walking ability and poor quality of life. Prior studies suggest that gait training with paretic lower limb loading may improve gait parameters and walking ability in post-stroke. However, most gait training methods used in these studies are not readily available, and studies using cheaper methods are limited.
Read the detailed description
Stroke is the second leading cause of death and a major public health problem in both developed and developing countries. It is one of the most common causes of long-term disabilities among adults.
Stroke survivors exhibit varying neurological deficits and impairments including sensory, cognitive, perceptual, emotional, speech and motor such as gait impairments. The most important motor deficit after a stroke is the paresis of the affected side, which reduces the capacity of the paretic lower limb to maintain normal functions such as balance, initiation, and control of movements, and this negatively affects their gait.
Gait is altered post-stroke due to basic motor impairments such as altered muscle tone, lack of selective motor control, abnormal reflexes, poor balance, and muscle weakness. Gait impairment is one of the hallmarks of stroke, and many survivors are reported to have slow motor recovery in the affected lower extremity years after the stroke, which impairs their gait quality and contributes to persistent gait asymmetry. Gait asymmetry implies a significant imbalance of functional activities between two sides of the body or lower limb.
Gait symmetry is a valuable feature of gait quality, and its abnormality negatively affects gait parameters. Post-stroke, 44%-62% of the survivors showed asymmetry in the spatial gait parameters, while 48%-82% developed asymmetry in the temporal gait parameters.
After a stroke, the paretic limb exhibits a prolonged period of swing and a reduced period of stance; as a result, decreased swing time and increased stance time are seen in the non-paretic limb. These changes are believed to result from decreased walking speed as well as disturbances in other gait parameters between the paretic and non-paretic limbs, which may limit gains from rehabilitation. Despite rehabilitation efforts, self-loading and self-initiation of gait are typically ineffective in stroke patients. Stroke rehabilitation now focuses on improving load transfer onto the paretic limb to enhance proprioception and gait symmetry by providing an external source of limb loading to augment patient effort. Many survivors usually do not have significant improvement in gait function. This is often due to inefficient weight application (limb loading) on the affected side, causing non-linear limb load transfer.
Though there have been numerous interventions to manage gait in stroke survivors, using weight during over-ground walk training on stroke survivors has not been thoroughly evaluated. However, a cross-sectional study has found that weight application at the knee and ankle were both found to influence the spatiotemporal gait parameters and gait symmetry, with ankle loading having more influence on more parameters. This study is hoped to serve as a follow-up RCT to the cross-sectional study by Bala (2019).
- Conditions
- Stroke, Hemiparesis;Poststroke/CVA
- Being tested
- Warm-up (5 minutes), Conventional physiotherapy exercise (15 minutes), Over-ground training with lower limb loading (15-25 minutes)
- Keywords
- Lower limb loading, Over-ground training, Spatiotemporal gait parameters, Gait symmetry parameters, Motor function, Randomized Controlled Trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm-up (5 minutes)Behavioural
Participants will benefit from passive stretches of hamstrings, calf muscles including a range of motion (ROM) exercise to the lower limbs as mat exercises.
Conventional physiotherapy exercise (15 minutes)Behavioural
The conventional treatments will be active-assisted and free active exercises to the lower limbs on the mat for five (5) minutes. This will be followed by strength training such as sit-to-stand exercises for five (5) minutes and squatting exercises for five (5) minutes prior to the over-ground training.
Over-ground training with lower limb loading (15-25 minutes)Behavioural
Participants will perform the over-ground training exercise with an external 1.5kg load on the paretic lower limb placed 2cm above the ankle joint. Before commencing the over-ground training, all the participants will observe a pre-exercise rest period of about two (2) minutes during which their heart rate and blood pressure measurements will be recorded.
The over-ground training will involve the patients walking within a demarcated path. Each participant will be instructed to stand and walk 15meters to and fro for five (5) minutes after which they will be asked to stop and rest for two (2) minutes. The over ground training exercise will be repeated 3 times in the first 2 weeks of the training (15 minutes); 4 times in weeks 3-4 of the training (20 minutes); and 5 times in weeks 5-8 of the training (25 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training with lower limb loading (15-25 minutes) Receives: Behavioral: Warm-up (5 minutes); Behavioral: Conventional physiotherapy exercise (15 minutes); Behavioral: Over-ground training with lower limb loading (15-25 minutes) |
| Control group | Active comparator | i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training WITHOUT lower limb loading (15-25 minutes) Receives: Behavioral: Warm-up (5 minutes); Behavioral: Conventional physiotherapy exercise (15 minutes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial gait parameters and symmetry
Each participant will perform three trials of walking and the spatial gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in centimeters (cm) using measuring tape each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step length, stride length, foot angle, and stride width.
Measured: Change from baseline spatial gait parameters at 4 weeks; Change from baseline spatial gait parameters at 8 weeks
Temporal gait parameters and symmetry
Each participant will perform three trials of walking and the temporal gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in seconds (sec) using a stop watch each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step time, stride time, single limb support time, stance time, swing time, cadence, and gait speed.
Measured: Change from baseline temporal gait parameters at 4 weeks; Change from baseline temporal gait parameters at 8 weeks
The Lower limb motor functions
The Motricity Index will be used to measure the lower limb functions of the participants. It is a reliable instrument for measuring the strength of the involved lower extremity when assessment following chronic stroke.
Participant position: The test is administered in a sitting position. Patient will be asked to sit on a chair or on the edge of the bed. In the lower limb, the three movements to be tested are: hip flexion, knee extension, and dorsiflexion. The assessment will be carried out just before the over-ground training. All the data will be recorded. Thereafter, the total score of each participant will then be computed and documented.
Scorings: 0 (No movement); 9 (Palpable contraction in muscle, but no movement); 14 (Visible movement, but not full range and not against gravity); 19 (Full range movement against gravity, but not resistance); 25 (Full movement against gravity, but weaker than the other side); 33 (Normal power).
Measured: Change from baseline lower limb motor function at 4 weeks; Change from baseline lower limb motor function at 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 Oct 2021
- Study start2 Aug 2021
- Primary completion25 Feb 2023
- Study completion14 Mar 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.
- 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
- Participants will be randomized into either group A (experimental: over-ground walking with lower limb loading) or group B (control: over-ground walking without lower limb loading). Both groups will receive a warm-up consisting of passive stretching to hamstrings and calf muscles, and a range of motion exercise to the lower limbs for 5 min. Participants allocated to group A will receive conventional exercises (15 min) and then rest for 2 min, then proceeded with overground walking training with lower limb loading (15-25 min), and rest for 2 min. Those assigned to group B will receive the same conventional exercises (15 min) and overground walking but without lower limb loading. Treatment in both groups will be delivered thrice weekly for 8 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayero University Kano, Nigeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulhamid Umar Maje, Bayero University Kano, Nigeria
- Investigators
- Abdulhamid U Maje, M.Sc., Principal investigator, Muhammadu Abdullahi Wase Teaching Hospital, Kano State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097391
- Sponsor's protocol ID
- SPS/18/MPT/00033
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maje AU, Ibrahim AA. Effectiveness of an 8-week overground walking with paretic lower limb loading on spatiotemporal gait parameters and motor function among chronic stroke survivors: a protocol for randomised controlled trial. Trials. 2023 Feb 20;24(1):124. doi: 10.1186/s13063-022-07057-3.
PubMed 36803399
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lower-limb Loading During Over-ground Training on Selected Gait Parameters and Motor Function of Stroke Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05097391
- Acronym / sponsor ID
- SPS/18/MPT/00033
- Conditions
- Stroke, Hemiparesis;Poststroke/CVA
- Keywords
- Lower limb loading, Over-ground training, Spatiotemporal gait parameters, Gait symmetry parameters, Motor function, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bayero University Kano, NigeriaUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 28 Oct 2021 (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.
Post-stroke gait deviations contribute to significant functional disability, impaired walking ability and poor quality of life. Prior studies suggest that gait training with paretic lower limb loading may improve gait parameters and walking ability in post-stroke. However, most gait training methods used in these studies are not readily available, and studies using cheaper methods are limited.
Detailed description
Stroke is the second leading cause of death and a major public health problem in both developed and developing countries. It is one of the most common causes of long-term disabilities among adults.
Stroke survivors exhibit varying neurological deficits and impairments including sensory, cognitive, perceptual, emotional, speech and motor such as gait impairments. The most important motor deficit after a stroke is the paresis of the affected side, which reduces the capacity of the paretic lower limb to maintain normal functions such as balance, initiation, and control of movements, and this negatively affects their gait.
Gait is altered post-stroke due to basic motor impairments such as altered muscle tone, lack of selective motor control, abnormal reflexes, poor balance, and muscle weakness. Gait impairment is one of the hallmarks of stroke, and many survivors are reported to have slow motor recovery in the affected lower extremity years after the stroke, which impairs their gait quality and contributes to persistent gait asymmetry. Gait asymmetry implies a significant imbalance of functional activities between two sides of the body or lower limb.
Gait symmetry is a valuable feature of gait quality, and its abnormality negatively affects gait parameters. Post-stroke, 44%-62% of the survivors showed asymmetry in the spatial gait parameters, while 48%-82% developed asymmetry in the temporal gait parameters.
After a stroke, the paretic limb exhibits a prolonged period of swing and a reduced period of stance; as a result, decreased swing time and increased stance time are seen in the non-paretic limb. These changes are believed to result from decreased walking speed as well as disturbances in other gait parameters between the paretic and non-paretic limbs, which may limit gains from rehabilitation. Despite rehabilitation efforts, self-loading and self-initiation of gait are typically ineffective in stroke patients. Stroke rehabilitation now focuses on improving load transfer onto the paretic limb to enhance proprioception and gait symmetry by providing an external source of limb loading to augment patient effort. Many survivors usually do not have significant improvement in gait function. This is often due to inefficient weight application (limb loading) on the affected side, causing non-linear limb load transfer.
Though there have been numerous interventions to manage gait in stroke survivors, using weight during over-ground walk training on stroke survivors has not been thoroughly evaluated. However, a cross-sectional study has found that weight application at the knee and ankle were both found to influence the spatiotemporal gait parameters and gait symmetry, with ankle loading having more influence on more parameters. This study is hoped to serve as a follow-up RCT to the cross-sectional study by Bala (2019).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into either group A (experimental: over-ground walking with lower limb loading) or group B (control: over-ground walking without lower limb loading). Both groups will receive a warm-up consisting of passive stretching to hamstrings and calf muscles, and a range of motion exercise to the lower limbs for 5 min. Participants allocated to group A will receive conventional exercises (15 min) and then rest for 2 min, then proceeded with overground walking training with lower limb loading (15-25 min), and rest for 2 min. Those assigned to group B will receive the same conventional exercises (15 min) and overground walking but without lower limb loading. Treatment in both groups will be delivered thrice weekly for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Warm-up (5 minutes), Behavioral: Conventional physiotherapy exercise (15 minutes), Behavioral: Over-ground training with lower limb loading (15-25 minutes)i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training with lower limb loading (15-25 minutes) |
| Control group | Active comparator | Behavioral: Warm-up (5 minutes), Behavioral: Conventional physiotherapy exercise (15 minutes)i - Warm-up (5 minutes) ii- Conventional physiotherapy exercise (15 minutes) iii - Over-ground training WITHOUT lower limb loading (15-25 minutes) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral ischemic or hemorrhagic stroke occurring at least 3 months before enrolment
- Male or female between the age of 20 and 70 years
- Having a Modified Rankin Scale (MRS) scores of 1, 2, or 3, and also able to walk at least 10 meters independently without an assistive device
- Ability to follow verbal instructions.
Key exclusion criteria (6 listed)
- Cognitive impairments
- Visual impairments
- Musculoskeletal disorders that may affect gait such as arthritis
- Other neurological disorders such as Parkinson's disease, multiple sclerosis
- Cardio-respiratory conditions that may limit participation such as atelectasis
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 |
|---|---|---|
| Warm-up (5 minutes)Participants will benefit from passive stretches of hamstrings, calf muscles including a range of motion (ROM) exercise to the lower limbs as mat exercises. | Behavioural | Control group, Experimental group |
| Conventional physiotherapy exercise (15 minutes)The conventional treatments will be active-assisted and free active exercises to the lower limbs on the mat for five (5) minutes. This will be followed by strength training such as sit-to-stand exercises for five (5) minutes and squatting exercises for five (5) minutes prior to the over-ground training. | Behavioural | Control group, Experimental group |
| Over-ground training with lower limb loading (15-25 minutes)Participants will perform the over-ground training exercise with an external 1.5kg load on the paretic lower limb placed 2cm above the ankle joint. Before commencing the over-ground training, all the participants will observe a pre-exercise rest period of about two (2) minutes during which their heart rate and blood pressure measurements will be recorded. The over-ground training will involve the patients walking within a demarcated path. Each participant will be instructed to stand and walk 15meters to and fro for five (5) minutes after which they will be asked to stop and rest for two (2) minutes. The over ground training exercise will be repeated 3 times in the first 2 weeks of the training (15 minutes); 4 times in weeks 3-4 of the training (20 minutes); and 5 times in weeks 5-8 of the training (25 minutes). | Behavioural | Experimental group |
Primary outcome
Spatial gait parameters and symmetry
Time frame: Change from baseline spatial gait parameters at 4 weeks; Change from baseline spatial gait parameters at 8 weeks
Each participant will perform three trials of walking and the spatial gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in centimeters (cm) using measuring tape each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step length, stride length, foot angle, and stride width.
Temporal gait parameters and symmetry
Time frame: Change from baseline temporal gait parameters at 4 weeks; Change from baseline temporal gait parameters at 8 weeks
Each participant will perform three trials of walking and the temporal gait parameters will be recorded in each trial; the average will be computed. The measurements will be carried out in seconds (sec) using a stop watch each for the paretic lower limb loading and paretic lower limb non-loading during the over-ground training. The parameters to be measured are: Step time, stride time, single limb support time, stance time, swing time, cadence, and gait speed.
The Lower limb motor functions
Time frame: Change from baseline lower limb motor function at 4 weeks; Change from baseline lower limb motor function at 8 weeks
The Motricity Index will be used to measure the lower limb functions of the participants. It is a reliable instrument for measuring the strength of the involved lower extremity when assessment following chronic stroke. Participant position: The test is administered in a sitting position. Patient will be asked to sit on a chair or on the edge of the bed. In the lower limb, the three movements to be tested are: hip flexion, knee extension, and dorsiflexion. The assessment will be carried out just before the over-ground training. All the data will be recorded. Thereafter, the total score of each participant will then be computed and documented. Scorings: 0 (No movement); 9 (Palpable contraction in muscle, but no movement); 14 (Visible movement, but not full range and not against gravity); 19 (Full range movement against gravity, but not resistance); 25 (Full movement against gravity, but weaker than the other side); 33 (Normal power).
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 22 Mar 2023.
- Derived from this study: PubMed 36803399Maje AU, Ibrahim AA. Effectiveness of an 8-week overground walking with paretic lower limb loading on spatiotemporal gait parameters and motor function among chronic stroke survivors: a protocol for randomised controlled trial. Trials. 2023 Feb 20;24(1):124. doi: 10.1186/s13063-022-07057-3.
- 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.
Abdulhamid U Maje, M.Sc. principal investigator
Muhammadu Abdullahi Wase Teaching Hospital, Kano State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm-up (5 minutes), Conventional physiotherapy exercise (15 minutes) and Over-ground training with lower limb loading (15-25 minutes) in people with Stroke and Hemiparesis;Poststroke/CVA, run by Bayero University Kano, Nigeria at 1 site in Nigeria.
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 4 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: finished, as of the sponsor's last update on 22 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 Nigeria. 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?
Spatial gait parameters and symmetry (time frame: Change from baseline spatial gait parameters at 4 weeks; Change from baseline spatial gait parameters at 8 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?
On the ClinicalTrials.gov record for NCT05097391, 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 22 Mar 2023.