StrokeNCT04491162
The Effect of Body Weight Support Treadmill Training on Lower Limb Function in Patients With Chronic Stroke
A study testing Body weight support treadmill training + conventional therapy and Conventional therapy in people with Stroke and Gait Disorder, Sensorimotor, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
Trial summary
Stroke has severe debilitating neurological consequences for the victim. Within context of this study, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or postural control. Gait disturbance has an unfavorable effect on functional independence and prognosis of patients. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Stroke, Gait Disorder, Sensorimotor
- What is being tested?
- Body weight support treadmill training + conventional therapy and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 1 Mar 2019
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 69 years, both genders will be acceptable.
- First episode of supratentorial stroke in hemiparesis (both ischaemic and haemorrhagic strokes)
- After 6 month from onset of stroke.
- All subjects were ambulatory before stroke
- Able to understand and follow simple verbal instruction, scoring at least 24 out of 30 on Mini Mental State Examination.
- Able to walk at least 10 meters distance independently, with or without a walking aids.
Show all 10Show fewer
- Walking speed<0.75m/s at their self-selected velocity (SSV).
- Scoring 3 or 4 in Functional Ambulation Category Scale.
- Scoring less than 21 out of 23 on trunk Impairment Scale.
- Currently not receiving any other type of physiotherapeutic intervention.
Who cannot join
- Neurological disease affecting balance other than stroke.
- History of diagnosed musculoskeletal disorder of the trunk and / or lower extremities affecting the motor performance.
- History of Cerebrovascular accident more than one time or bilateral CVA at a time.
- Myocardial infarction within the past 6 months.
- Angina or ischemia at rest or during exercise.
- Unstable hypertension (>150/90 mmHg), arrhythmia, congestive heart failure or unstable cardio vascular status.
- Absence of active movement in the paretic lower limbs.
- Disability of joint including hip fracture and severe cardio pulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
Stroke has severe debilitating neurological consequences for the victim. Within context of this study, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or postural control. Gait disturbance has an unfavorable effect on functional independence and prognosis of patients. Due to this reason, recovery in gait ability of stroke patients is considered as a very important goal in rehabilitation.
Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait restoration after stroke. The present study focused on the possibility of BWSTT as a special program for improving gait ability. The purpose of this study was to evaluate the effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.
Read the detailed description
Stroke is thought to be a serious health problem which can cause severe disabilities. Aspects of disabilities caused by stroke are various according to the affected region and its severity. In general, sensory deficits, cognitive problem, motor impairment, visual perceptual disorders and dysphagia mainly occur among stroke patients. In particular, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or postural control. This gait disturbance is exhibited as an asymmetric gait pattern, such as a decrease in paretic side stance phase and non-paretic swing phase, cadence, velocity and difference in step length and stride length. Therefore, these differences create abnormal gait patterns in stroke patients. Furthermore, gait disturbance has an unfavorable effect on functional independence and prognosis of patients. Due to this reason, recovery in gait ability of stroke patients is considered as a very important goal in rehabilitation.
Gait performance is an indicator of mobility impairment and disability after stroke. It predicts mortality, morbidity, and risk of future stroke. Gait speed is responsive to short-term rehabilitation. An improvement in gait speed of 0.16 m/s can reduce the level of assistance in patients with subacute stroke and was recommended to be the minimum clinically significant difference. The control of gait involves the planning and execution from multiple cortical areas, such as secondary and premotor cortex. Stroke patients often have gait impairment such as decreased gait speed and asymmetrical gait cycle as a result of cortical reorganization. Repetitive mass motor task practice had been shown to facilitate neuroplasticity and brain reorganization in stroke patients, resulting in enhanced motor recovery after stroke.
Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait restoration after stroke. BWSTT has the advantage over conventional therapy as it offers higher intensity, more repetitive and task-oriented practice over the same period of time when compared to conventional therapy. Several studies have showed that BWSTT was more effective in gait speed improvement than regular physiotherapy. It has been demonstrated that BWSTT induces changes in corticomotor excitability which lead to improved balance and gait performance with chronic stroke. However, other studies have reported that BWSTT was not superior to conventional gait training.
Recent studies have reported that BWSTT can increase walking endurance in the subacute stage after stroke, but no improvement was reported in balance and 10 m gait speed. To date, there are very few studies that have used gait analysis to show how the improvements in gait parameters come about after BWSTT or conventional therapy. There is still a lack of basic understanding of gait training on human locomotion.
Despite substantial recovery of independent ambulation by survivors following unilateral stroke, persistent gait abnormalities are observed in a large percentage of these persons. In these circumstances, a short-term intermittent and intensive rehabilitation program for chronic stroke survivors is thought to be particularly efficient for shoring up their independence, and the present study focused on the possibility of BWSTT as a special program for improving gait ability. The purpose of this study was to evaluate the effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.
- Conditions
- Stroke, Gait Disorder, Sensorimotor
- Being tested
- Body weight support treadmill training + conventional therapy, Conventional therapy
- Keywords
- Rehabilitation, Body weight supported treadmill training
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body weight support treadmill training + conventional therapyOther
Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.
Patients in intervention arm were additionally trained with a 40% body weight support and a comfortable walking speed on treadmill for twenty minutes. The training, which was conducted three times a week, for period of two weeks.
Conventional therapyOther
Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.
| Study group | Role | What they receive |
|---|---|---|
| Conventional gait therapy | Active comparator | Conventional gait therapy. Receives: Other: Conventional therapy |
| BWST training | Experimental | Conventional gait therapy + Body weight support treadmill training Receives: Other: Body weight support treadmill training + conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Measured: Two weeks
Secondary outcomes (3)
Cadence
Cadence is measured as number of steps per minute during a 10 metre walk.
Measured: Two weeks
Timed up and go test
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: Two weeks
Berg Balance Scale
It is a widely used clinical test for static and dynamic balance. It comprises of 14 balance related tasks. A score of less than 20 signifies wheelchair use; 20-40: walking with assistance; 40-56: Independent ambulator.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
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.
- 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
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
- Investigators
- Madhusree Sengupta, MD, PDF, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491162
- Sponsor's protocol ID
- INK/ Rehab/ BWS/2016
- Status last verified
- Jul 2020
- First submitted
- 18 May 2020
- Last updated
- 29 Jul 2020
- 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Weight Support Treadmill Training on Lower Limb Function in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04491162
- Acronym / sponsor ID
- INK/ Rehab/ BWS/2016
- Conditions
- Stroke, Gait Disorder, Sensorimotor
- Keywords
- Rehabilitation, Body weight supported treadmill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 29 Jul 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.
Stroke has severe debilitating neurological consequences for the victim. Within context of this study, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or postural control. Gait disturbance has an unfavorable effect on functional independence and prognosis of patients. Due to this reason, recovery in gait ability of stroke patients is considered as a very important goal in rehabilitation.
Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait restoration after stroke. The present study focused on the possibility of BWSTT as a special program for improving gait ability. The purpose of this study was to evaluate the effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.
Detailed description
Stroke is thought to be a serious health problem which can cause severe disabilities. Aspects of disabilities caused by stroke are various according to the affected region and its severity. In general, sensory deficits, cognitive problem, motor impairment, visual perceptual disorders and dysphagia mainly occur among stroke patients. In particular, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or postural control. This gait disturbance is exhibited as an asymmetric gait pattern, such as a decrease in paretic side stance phase and non-paretic swing phase, cadence, velocity and difference in step length and stride length. Therefore, these differences create abnormal gait patterns in stroke patients. Furthermore, gait disturbance has an unfavorable effect on functional independence and prognosis of patients. Due to this reason, recovery in gait ability of stroke patients is considered as a very important goal in rehabilitation.
Gait performance is an indicator of mobility impairment and disability after stroke. It predicts mortality, morbidity, and risk of future stroke. Gait speed is responsive to short-term rehabilitation. An improvement in gait speed of 0.16 m/s can reduce the level of assistance in patients with subacute stroke and was recommended to be the minimum clinically significant difference. The control of gait involves the planning and execution from multiple cortical areas, such as secondary and premotor cortex. Stroke patients often have gait impairment such as decreased gait speed and asymmetrical gait cycle as a result of cortical reorganization. Repetitive mass motor task practice had been shown to facilitate neuroplasticity and brain reorganization in stroke patients, resulting in enhanced motor recovery after stroke.
Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait restoration after stroke. BWSTT has the advantage over conventional therapy as it offers higher intensity, more repetitive and task-oriented practice over the same period of time when compared to conventional therapy. Several studies have showed that BWSTT was more effective in gait speed improvement than regular physiotherapy. It has been demonstrated that BWSTT induces changes in corticomotor excitability which lead to improved balance and gait performance with chronic stroke. However, other studies have reported that BWSTT was not superior to conventional gait training.
Recent studies have reported that BWSTT can increase walking endurance in the subacute stage after stroke, but no improvement was reported in balance and 10 m gait speed. To date, there are very few studies that have used gait analysis to show how the improvements in gait parameters come about after BWSTT or conventional therapy. There is still a lack of basic understanding of gait training on human locomotion.
Despite substantial recovery of independent ambulation by survivors following unilateral stroke, persistent gait abnormalities are observed in a large percentage of these persons. In these circumstances, a short-term intermittent and intensive rehabilitation program for chronic stroke survivors is thought to be particularly efficient for shoring up their independence, and the present study focused on the possibility of BWSTT as a special program for improving gait ability. The purpose of this study was to evaluate the effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional gait therapy | Active comparator | Other: Conventional therapyConventional gait therapy. |
| BWST training | Experimental | Other: Body weight support treadmill training + conventional therapyConventional gait therapy + Body weight support treadmill training |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 and 69 years, both genders will be acceptable.
- First episode of supratentorial stroke in hemiparesis (both ischaemic and haemorrhagic strokes)
- After 6 month from onset of stroke.
- All subjects were ambulatory before stroke
- Able to understand and follow simple verbal instruction, scoring at least 24 out of 30 on Mini Mental State Examination.
Key exclusion criteria (8 listed)
- Neurological disease affecting balance other than stroke.
- History of diagnosed musculoskeletal disorder of the trunk and / or lower extremities affecting the motor performance.
- History of Cerebrovascular accident more than one time or bilateral CVA at a time.
- Myocardial infarction within the past 6 months.
- Angina or ischemia at rest or during exercise.
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 |
|---|---|---|
| Body weight support treadmill training + conventional therapyConventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts. Patients in intervention arm were additionally trained with a 40% body weight support and a comfortable walking speed on treadmill for twenty minutes. The training, which was conducted three times a week, for period of two weeks. | Other | BWST training |
| Conventional therapyConventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts. | Other | Conventional gait therapy |
Primary outcome
10 meter walk test
Time frame: Two weeks
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
3 secondary outcomes
Cadence
Time frame: Two weeks
Timed up and go test
Time frame: Two weeks
Berg Balance Scale
Time frame: Two weeks
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 29 Jul 2020.
- 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.
Madhusree Sengupta, MD, PDF principal investigator
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body weight support treadmill training + conventional therapy and Conventional therapy in people with Stroke and Gait Disorder, Sensorimotor, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
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 10 inclusion and 8 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 29 Jul 2020. 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 India. 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?
10 meter walk test (time frame: Two weeks). 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 29 Jul 2020.