StrokeNCT04597658
The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients
A study testing Bodyweight supported treadmill training (BWSTT) and Conventional rehabilitation in people with Stroke and Cerebrovascular Accident, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to evaluate the effects of exercise on body weight-supported treadmill in stroke patients on gait parameters, activity, body functions and quality of life, and to determine whether it has an effect on balance when applied in addition to conventional therapy. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Gait Disorders, Neurologic
- What is being tested?
- Bodyweight supported treadmill training (BWSTT) and Conventional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 May 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have had an ischemic or hemorrhagic stroke
- A history of the cerebrovascular event
- Patients who can walk 10 meters with or without an assistive device and / or orthosis (Patients with lower extremity motor functions above 2 according to Brunnstrom staging)
- Patients with comfortable walking speed <1.0 m / s
- Patients who can follow verbal warnings (patients with Mini-mental test score > 19)
Who cannot join
- Patients with a stroke less than a month
- Patients with stage 0 (non-functional ambulation) and stage 1 (the person's manual support is continuous) according to the functional ambulation scale
- Presence of serious cardiovascular or respiratory system diseases that prevent exercising
- Presence of uncontrolled metabolic disease (uncontrolled diabetes)
- Participation in an intensive rehabilitation program in the last month and continuing
- Presence of arthritis or severe contracture in the lower limb that may affect walking
- Presence of other accompanying neuromuscular diseases (such as Parkinson's disease)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34093
About this study
Official title: The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients: Randomized Controlled Study
In this study, the investigators aimed to evaluate the effects of exercise on body weight-supported treadmill in stroke patients on gait parameters, activity, body functions and quality of life, and to determine whether it has an effect on balance when applied in addition to conventional therapy.
Read the detailed description
The study was planned as an open, prospective, randomized, single-blind study, and it was planned by the researchers to include 30 patients with stroke who applied to the Neurology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine, Department of Physical Therapy and Rehabilitation. It was planned that the "Informed Consent Form" prepared before the study would be signed by the patient before being included in the study, and patient evaluation and follow-up forms would be filled in before and after the treatment.
Patients who meet the inclusion criteria at the beginning of the study will be numbered according to the order of application and randomly divided into two groups with the computer program. Group number 1 Treadmill with Weight Support; Group number 2 will be determined as the Conventional Rehabilitation group. In addition to the traditional rehabilitation program and rehabilitation program to both groups, one group will be given body weight support and treadmill therapy. The treatment will be applied as 15 sessions 5 days a week.
A traditional rehabilitation program will be applied to both groups. Posture and breathing exercises, lower extremity stretching, active auxiliary range of motion, and strengthening exercises will be applied. Electrical stimulation will not be delivered to the lower limb. Balance coordination exercises - sitting in a chair (individually shaped according to the patient's balance), holding it in a safe place if necessary; standing without support, standing quietly, heel tip, standing on one leg, and holding onto a chair). Patients will be asked to walk on a smooth surface in the company with a physiotherapist, using an assistive device, if any. The rehabilitation program is planned to last 30 minutes in total.
In the group where the bodyweight supported treadmill will be applied, patients will be asked to walk on the treadmill as fast as possible without exceeding the medium intensity according to the Borg scale. - Perceived fatigue on the Borg scale is quite mild 10-12. (40-50% of the maximum heart rate). Care should be taken that the patient wears appropriate shoes and clothing during walking.
In the beginning, 30% of the whole body weight will not be loaded. Bodyweight support will be reduced to 15% according to the tolerance of the patient. Later, when the patients can tolerate the speed of 2km / hour, they will not take more than two breaks during the 30-minute session, and 0% support will be applied when they are able to perform optimal walking without the need for at least 5 minutes of surveillance support. In the treatment to be performed under the guidance of a physiotherapist, manual intervention to the pelvis, trunk, and/or paretic extremity will correct the gait pattern. At the same time, verbal stimulation will ensure that temporal characteristics of the gait such as step length and walking speed are appropriate and at the same time the patient is motivated.
- Being tested
- Bodyweight supported treadmill training (BWSTT), Conventional rehabilitation
- Medical subject headings
- Stroke, Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodyweight supported treadmill training (BWSTT)Behavioural
In the BWSTT group, walking training will be given by asking the patients to walk on the treadmill as fast as they can, without exceeding the medium intensity according to the Borg scale. Bodyweight support will be gradually reduced according to the patient's tolerance.
Conventional rehabilitationBehavioural
The conventional rehabilitation program includes posture and breathing exercises, lower extremity stretching, active-assistive range of motion and strengthening, balance-coordination exercises, and walking with a physiotherapist on a smooth surface.
| Study group | Role | What they receive |
|---|---|---|
| Conventional rehabilitation | Active comparator | Not described Receives: Behavioral: Conventional rehabilitation |
| Body weightsupported treadmill training | Experimental | Not described Receives: Behavioral: Bodyweight supported treadmill training (BWSTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The 10 Metre Walk Test
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance.
Measured: Baseline (before intervention), immediately after intervention
Secondary outcomes (4)
Change in The Rivermead Mobility Index Score
The Rivermead Mobility Index is a one-dimensional index that focuses on measuring mobility status and includes basic mobility activities. It consists of 14 questions and one observation and includes a series of hierarchical activities from turning in bed to running.
Measured: Baseline (before intervention), immediately after intervention
Change in The 6 Minute Walk Test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline (before intervention), immediately after intervention
Change in Stroke Specific Quality of Life Scale Score
Stroke Specific Quality of Life Scale is one of the most comprehensive scales which measures quality of life in patients with stroke. It consists of 49 questions (each question is scored on a five points scale, 1-5) covering 12 domains (mobility, upper limb functions, social role, energy, self-care, family role, work-productivity, language, mood, personality, thinking, and vision). Each domain score is calculated by taking the unweighted means of associated questions while the unweighted mean of all the domains is used to calculate the total score.
Measured: Baseline (before intervention), immediately after intervention
Change in Tinetti Balance and Gait Assessment Score
The Tinetti Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. IN general, residents who score below 19 are at a high risk for falls. Residents who score in the range of 19 - 24 points indicate that the resident has a risk for falls.
Measured: Baseline (before intervention), immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jan 2021
- Primary completion1 Jul 2021
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Tarihçi, Istanbul University
- Investigators
- Elif Tarihçi, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597658
- Sponsor's protocol ID
- ITF, PMR
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Middleton A, Merlo-Rains A, Peters DM, Greene JV, Blanck EL, Moran R, Fritz SL. Body weight-supported treadmill training is no better than overground training for individuals with chronic stroke: a randomized controlled trial. Top Stroke Rehabil. 2014 Nov-Dec;21(6):462-76. doi: 10.1310/tsr2106-462.
PubMed 25467394Gama GL, Celestino ML, Barela JA, Forrester L, Whitall J, Barela AM. Effects of Gait Training With Body Weight Support on a Treadmill Versus Overground in Individuals With Stroke. Arch Phys Med Rehabil. 2017 Apr;98(4):738-745. doi: 10.1016/j.apmr.2016.11.022. Epub 2016 Dec 27.
PubMed 28034719Combs-Miller SA, Kalpathi Parameswaran A, Colburn D, Ertel T, Harmeyer A, Tucker L, Schmid AA. Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial. Clin Rehabil. 2014 Sep;28(9):873-84. doi: 10.1177/0269215514520773. Epub 2014 Feb 11.
PubMed 24519922Tarihci Cakmak E, Yaliman A, Torna G, Sen EI. The effectiveness of bodyweight-supported treadmill training in stroke patients: randomized controlled trial. Neurol Sci. 2024 Jul;45(7):3277-3285. doi: 10.1007/s10072-024-07385-z. Epub 2024 Feb 16.
PubMed 38363446
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Body Weight Supported Treadmill Training in Stroke Patients: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04597658
- Acronym / sponsor ID
- ITF, PMR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 22 Oct 2020 (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.
In this study, the investigators aimed to evaluate the effects of exercise on body weight-supported treadmill in stroke patients on gait parameters, activity, body functions and quality of life, and to determine whether it has an effect on balance when applied in addition to conventional therapy.
Detailed description
The study was planned as an open, prospective, randomized, single-blind study, and it was planned by the researchers to include 30 patients with stroke who applied to the Neurology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine, Department of Physical Therapy and Rehabilitation. It was planned that the "Informed Consent Form" prepared before the study would be signed by the patient before being included in the study, and patient evaluation and follow-up forms would be filled in before and after the treatment.
Patients who meet the inclusion criteria at the beginning of the study will be numbered according to the order of application and randomly divided into two groups with the computer program. Group number 1 Treadmill with Weight Support; Group number 2 will be determined as the Conventional Rehabilitation group. In addition to the traditional rehabilitation program and rehabilitation program to both groups, one group will be given body weight support and treadmill therapy. The treatment will be applied as 15 sessions 5 days a week.
A traditional rehabilitation program will be applied to both groups. Posture and breathing exercises, lower extremity stretching, active auxiliary range of motion, and strengthening exercises will be applied. Electrical stimulation will not be delivered to the lower limb. Balance coordination exercises - sitting in a chair (individually shaped according to the patient's balance), holding it in a safe place if necessary; standing without support, standing quietly, heel tip, standing on one leg, and holding onto a chair). Patients will be asked to walk on a smooth surface in the company with a physiotherapist, using an assistive device, if any. The rehabilitation program is planned to last 30 minutes in total.
In the group where the bodyweight supported treadmill will be applied, patients will be asked to walk on the treadmill as fast as possible without exceeding the medium intensity according to the Borg scale. - Perceived fatigue on the Borg scale is quite mild 10-12. (40-50% of the maximum heart rate). Care should be taken that the patient wears appropriate shoes and clothing during walking.
In the beginning, 30% of the whole body weight will not be loaded. Bodyweight support will be reduced to 15% according to the tolerance of the patient. Later, when the patients can tolerate the speed of 2km / hour, they will not take more than two breaks during the 30-minute session, and 0% support will be applied when they are able to perform optimal walking without the need for at least 5 minutes of surveillance support. In the treatment to be performed under the guidance of a physiotherapist, manual intervention to the pelvis, trunk, and/or paretic extremity will correct the gait pattern. At the same time, verbal stimulation will ensure that temporal characteristics of the gait such as step length and walking speed are appropriate and at the same time the patient is motivated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional rehabilitation | Active comparator | Behavioral: Conventional rehabilitation |
| Body weightsupported treadmill training | Experimental | Behavioral: Bodyweight supported treadmill training (BWSTT) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have had an ischemic or hemorrhagic stroke
- A history of the cerebrovascular event
- Patients who can walk 10 meters with or without an assistive device and / or orthosis (Patients with lower extremity motor functions above 2 according to Brunnstrom staging)
- Patients with comfortable walking speed <1.0 m / s
- Patients who can follow verbal warnings (patients with Mini-mental test score > 19)
Key exclusion criteria (7 listed)
- Patients with a stroke less than a month
- Patients with stage 0 (non-functional ambulation) and stage 1 (the person's manual support is continuous) according to the functional ambulation scale
- Presence of serious cardiovascular or respiratory system diseases that prevent exercising
- Presence of uncontrolled metabolic disease (uncontrolled diabetes)
- Participation in an intensive rehabilitation program in the last month and continuing
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 |
|---|---|---|
| Bodyweight supported treadmill training (BWSTT)In the BWSTT group, walking training will be given by asking the patients to walk on the treadmill as fast as they can, without exceeding the medium intensity according to the Borg scale. Bodyweight support will be gradually reduced according to the patient's tolerance. | Behavioural | Body weightsupported treadmill training |
| Conventional rehabilitationThe conventional rehabilitation program includes posture and breathing exercises, lower extremity stretching, active-assistive range of motion and strengthening, balance-coordination exercises, and walking with a physiotherapist on a smooth surface. | Behavioural | Conventional rehabilitation |
Primary outcome
Change in The 10 Metre Walk Test
Time frame: Baseline (before intervention), immediately after intervention
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance.
4 secondary outcomes
Change in The Rivermead Mobility Index Score
Time frame: Baseline (before intervention), immediately after intervention
Change in The 6 Minute Walk Test
Time frame: Baseline (before intervention), immediately after intervention
Change in Stroke Specific Quality of Life Scale Score
Time frame: Baseline (before intervention), immediately after intervention
Change in Tinetti Balance and Gait Assessment Score
Time frame: Baseline (before intervention), immediately after intervention
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 24 Nov 2023.
- Background: PubMed 25467394Middleton A, Merlo-Rains A, Peters DM, Greene JV, Blanck EL, Moran R, Fritz SL. Body weight-supported treadmill training is no better than overground training for individuals with chronic stroke: a randomized controlled trial. Top Stroke Rehabil. 2014 Nov-Dec;21(6):462-76. doi: 10.1310/tsr2106-462.
- Background: PubMed 28034719Gama GL, Celestino ML, Barela JA, Forrester L, Whitall J, Barela AM. Effects of Gait Training With Body Weight Support on a Treadmill Versus Overground in Individuals With Stroke. Arch Phys Med Rehabil. 2017 Apr;98(4):738-745. doi: 10.1016/j.apmr.2016.11.022. Epub 2016 Dec 27.
- Background: PubMed 24519922Combs-Miller SA, Kalpathi Parameswaran A, Colburn D, Ertel T, Harmeyer A, Tucker L, Schmid AA. Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial. Clin Rehabil. 2014 Sep;28(9):873-84. doi: 10.1177/0269215514520773. Epub 2014 Feb 11.
- Derived from this study: PubMed 38363446Tarihci Cakmak E, Yaliman A, Torna G, Sen EI. The effectiveness of bodyweight-supported treadmill training in stroke patients: randomized controlled trial. Neurol Sci. 2024 Jul;45(7):3277-3285. doi: 10.1007/s10072-024-07385-z. Epub 2024 Feb 16.
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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.
Elif Tarihçi, MD principal investigator
Istanbul 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 Bodyweight supported treadmill training (BWSTT) and Conventional rehabilitation in people with Stroke and Cerebrovascular Accident, run by Istanbul University at 1 site in Turkey (Türkiye).
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 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 24 Nov 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 Turkey (Türkiye). 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?
Change in The 10 Metre Walk Test (time frame: Baseline (before intervention), immediately after intervention). 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 NCT04597658, which also lists 4 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 24 Nov 2023.