StrokeNCT02710773
Backward Treadmill Training in Patients With Chronic Stroke
A study testing Backward Walking Treadmill Training and Treadmill Training in people with Stroke, run by Universita di Verona at 1 site in Italy.
Trial summary
Gait impairment is a common cause of disability in patients who have experienced a stroke and recovery of walking is a priority goal. Gait outcome is a significant factor that influences a patient's chance of returning to the social life activity and rehabilitation is an effective treatment for restoring gait in these… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Backward Walking Treadmill Training and Treadmill Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Dec 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemia brain injury or intracerebral hemorrhage by MRI or computed tomography at least 6 months before the onset of the study;
- age between 18 and 75 years;
- ability to walk independently for at least 15 meters;
- Functional Ambulatory Category level score 2 or less;
- Ability to walk in the treadmill at >0.3 km/h for 3 minutes handrail support;
Who cannot join
- presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking;
- aphasia with inability to follow 2 consecutive step commands, or a cognitive deficit;
- any uncontrolled health condition for which exercise is contraindicated
- Mini Mental State Examination <20;
- Unstable angina pectoris;
- Unstable cardiac conditions;
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- Complex ventricular arrhythmia;
- Resting systolic blood pressure >200 mm/Hg - Resting diastolic blood pressure >100 mm/Hg;
- Aphasia (unable to follow two commands);
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Verona, Italy, Verona, 37134
Nicola Smania, +39 0458124573, nicola.smania@univr.it
Daniele Munari, +39 0458124573, daniele.munari@univr.it
About this study
Official title: Effects of Backward Treadmill Training on Spasticity and Gait Ability in Patients With Chronic Stroke: a Randomized Controlled Trial
Gait impairment is a common cause of disability in patients who have experienced a stroke and recovery of walking is a priority goal. Gait outcome is a significant factor that influences a patient's chance of returning to the social life activity and rehabilitation is an effective treatment for restoring gait in these patients. Learning to walk backwards correctly has been recommended to improve the movement components required for walking forwards. Several studies demonstrated that during backward walking the muscle activity is higher, more oxygen consumption, metabolic and cardiorespiratory activity are required and the same motor program is used comparing to during the forward walking. It has been suggested that backward walking therapy may be promoted as a treatment strategy to improve gait in stroke patients.
The main goal of this project is to investigate the effectiveness of the backward walking therapy on gait improvement and spasticity in post stroke patients.
Read the detailed description
Loss of walking ability is a one of the major problem after stroke and recovery of walking is a priority goal for most patients. Several studies demonstrated that rehabilitation could be an effective treatment on improving gait following stroke. Learning to walk backwards correctly has been recommended to improve the movement components required for walking forwards. Backward walking, therefore, has been promoted as a treatment strategy to improve gait. During backward walking the same motor programme is used as during forward walking, but possibly running in reverse. It has been suggested that backward walking may offer some benefits beyond those experienced through forward walking alone. Backward walking appears to create more muscle activity in proportion to effort than forward walking. This suggests a greater level of energy expenditure in backward walking than in forward walking. Additionally, backward walking also demands a greater oxygen consumption, metabolic response and cardiorespiratory than forward walking. Up to our knowledge, only two studies demonstrated the positive effects of an additional backward walking training in post stroke patients. Yang and coll. examined the effectiveness of additional backward walking training on gait outcome of 25 subacute stroke patients and they demonstrated that asymmetric gait pattern could improve. In a recently study, a randomized control trail was conducted on 36 acute stroke patients evaluating the efficacy of a walk backwards on a treadmill. The patients were randomly allocated to three groups and they received 3 weeks of intervention: first group (n=12) underwent partial body weight support treadmill training in backwards, the second group (n=12) received partial body weight support treadmill training and the third group underwent conventional rehabilitation training. The results showed significant improvements in walking speed and in the rivermead Mobility Index, suggesting that Partial Body Weight Support treadmill backward training for patients in the early phase of acute stroke is effective at improving mobility.
Recently, gait rehabilitation methods in patients with neurological impairment have relied on technological devices, which drive the patient's gait in a body-weight support condition and emphasize the beneficial role of repetitive practice. The rationale for these approaches originates from animal studies which have shown that repetition of gait movements may enhance spinal and supraspinal locomotor circuits.
Two reviews concludes that treadmill training with partial body weight support is effective to improve walking speed and endurance without worsening gait quality
- Conditions
- Stroke
- Being tested
- Backward Walking Treadmill Training, Treadmill Training
- Keywords
- Gait, Randomized controlled trial, Chronic Stroke, Treadmill training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward Walking Treadmill TrainingOther
The intervention will consist of 5 minutes of forward walking (warm-up phase), 10 minutes of backward walking (intervention phase) and 5 minutes of forward walking (cool-down phase). The session will be performed on a treadmill device. The backward training speed will be increase consecutively: during the week 1, the intervention will be performed at 0,8 km/h; during the week 2 the speed will be 1,0 km/h; finally, during the week 3 the speed will be increased till 1,2 km/h.
Treadmill TrainingOther
The intervention will consist of 20 minutes of forward walking on a treadmill device.
| Study group | Role | What they receive |
|---|---|---|
| Backward Walking Treadmill Training | Experimental | The subjects will perform a backward walking training on treadmill device Receives: Other: Backward Walking Treadmill Training |
| Treadmill training | Active comparator | The subjects will perform a walking training on treadmill device Receives: Other: Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters Walking test (10-MtWT) change in gait speed
the test has been selected as a measure of gait speed. This is a validated test requiring individuals to walk on a flat hard floor at their fastest speed foe 10 meters. Scoring is walking speed.
Measured: Baseline time 0 and up to 16 weeks
Secondary outcomes (7)
Gait analysis
It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.
Measured: Baseline time 0 and up to 16 weeks
Stroke Impact scale
this 64-item questionnaire is self- administered, with each item scored on a 5-point Likert scale, and assesses 8 domains of stroke.
Measured: Baseline time 0 and up to 16 weeks
Health Survey Questionnaire short form 36
this is a multi- purpose, short form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and preference-based health index. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group.
Measured: Baseline time 0 and up to 16 weeks
Modified Ashworth Scale
Measured: Baseline time 0 and up to 16 weeks
Modified "Tardieu" Scale
Tardieu is a scale for measuring spasticity that takes into account resistance to passive movement at both slow and fast speed. The scale originally began development in the 1950s and has gone through multiple revisions (reviewed in Haugh 2006
Measured: Baseline time 0 and up to 16 weeks
Body's Centre of Pressure length (mm)
the static balance will be carried out with a monaxial platform, an electronic system used for the evaluation of the length of the centre of pressure (CoP)
Measured: Baseline time 0 and up to 16 weeks
Body's Centre of Pressure Area Path (mm2)
the static balance will be carried out with a monaxial platform, an electronic system used for the evaluation of the area path of the centre of pressure (CoP)
Measured: Baseline time 0 and up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
- Investigators
- Nicola Nicola, MD, Principal investigator, Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710773
- Sponsor's protocol ID
- BWTreadmillSTROKE
- Status last verified
- Sep 2016
- First submitted
- 23 Feb 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Backward Treadmill Training on Spasticity and Gait Ability in Patients With Chronic Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02710773
- Acronym / sponsor ID
- BWTreadmillSTROKE
- Conditions
- Stroke
- Keywords
- Gait, Randomized controlled trial, Chronic Stroke, Treadmill training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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.
Gait impairment is a common cause of disability in patients who have experienced a stroke and recovery of walking is a priority goal. Gait outcome is a significant factor that influences a patient's chance of returning to the social life activity and rehabilitation is an effective treatment for restoring gait in these patients. Learning to walk backwards correctly has been recommended to improve the movement components required for walking forwards. Several studies demonstrated that during backward walking the muscle activity is higher, more oxygen consumption, metabolic and cardiorespiratory activity are required and the same motor program is used comparing to during the forward walking. It has been suggested that backward walking therapy may be promoted as a treatment strategy to improve gait in stroke patients.
The main goal of this project is to investigate the effectiveness of the backward walking therapy on gait improvement and spasticity in post stroke patients.
Detailed description
Loss of walking ability is a one of the major problem after stroke and recovery of walking is a priority goal for most patients. Several studies demonstrated that rehabilitation could be an effective treatment on improving gait following stroke. Learning to walk backwards correctly has been recommended to improve the movement components required for walking forwards. Backward walking, therefore, has been promoted as a treatment strategy to improve gait. During backward walking the same motor programme is used as during forward walking, but possibly running in reverse. It has been suggested that backward walking may offer some benefits beyond those experienced through forward walking alone. Backward walking appears to create more muscle activity in proportion to effort than forward walking. This suggests a greater level of energy expenditure in backward walking than in forward walking. Additionally, backward walking also demands a greater oxygen consumption, metabolic response and cardiorespiratory than forward walking. Up to our knowledge, only two studies demonstrated the positive effects of an additional backward walking training in post stroke patients. Yang and coll. examined the effectiveness of additional backward walking training on gait outcome of 25 subacute stroke patients and they demonstrated that asymmetric gait pattern could improve. In a recently study, a randomized control trail was conducted on 36 acute stroke patients evaluating the efficacy of a walk backwards on a treadmill. The patients were randomly allocated to three groups and they received 3 weeks of intervention: first group (n=12) underwent partial body weight support treadmill training in backwards, the second group (n=12) received partial body weight support treadmill training and the third group underwent conventional rehabilitation training. The results showed significant improvements in walking speed and in the rivermead Mobility Index, suggesting that Partial Body Weight Support treadmill backward training for patients in the early phase of acute stroke is effective at improving mobility.
Recently, gait rehabilitation methods in patients with neurological impairment have relied on technological devices, which drive the patient's gait in a body-weight support condition and emphasize the beneficial role of repetitive practice. The rationale for these approaches originates from animal studies which have shown that repetition of gait movements may enhance spinal and supraspinal locomotor circuits.
Two reviews concludes that treadmill training with partial body weight support is effective to improve walking speed and endurance without worsening gait quality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Backward Walking Treadmill Training | Experimental | Other: Backward Walking Treadmill TrainingThe subjects will perform a backward walking training on treadmill device |
| Treadmill training | Active comparator | Other: Treadmill TrainingThe subjects will perform a walking training on treadmill device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of ischemia brain injury or intracerebral hemorrhage by MRI or computed tomography at least 6 months before the onset of the study;
- age between 18 and 75 years;
- ability to walk independently for at least 15 meters;
- Functional Ambulatory Category level score 2 or less;
- Ability to walk in the treadmill at >0.3 km/h for 3 minutes handrail support;
Key exclusion criteria (9 listed)
- presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking;
- aphasia with inability to follow 2 consecutive step commands, or a cognitive deficit;
- any uncontrolled health condition for which exercise is contraindicated
- Mini Mental State Examination <20;
- Unstable angina pectoris;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Backward Walking Treadmill TrainingThe intervention will consist of 5 minutes of forward walking (warm-up phase), 10 minutes of backward walking (intervention phase) and 5 minutes of forward walking (cool-down phase). The session will be performed on a treadmill device. The backward training speed will be increase consecutively: during the week 1, the intervention will be performed at 0,8 km/h; during the week 2 the speed will be 1,0 km/h; finally, during the week 3 the speed will be increased till 1,2 km/h. | Other | Backward Walking Treadmill Training |
| Treadmill TrainingThe intervention will consist of 20 minutes of forward walking on a treadmill device. | Other | Treadmill training |
Primary outcome
10 meters Walking test (10-MtWT) change in gait speed
Time frame: Baseline time 0 and up to 16 weeks
the test has been selected as a measure of gait speed. This is a validated test requiring individuals to walk on a flat hard floor at their fastest speed foe 10 meters. Scoring is walking speed.
7 secondary outcomes
Gait analysis
Time frame: Baseline time 0 and up to 16 weeks
Stroke Impact scale
Time frame: Baseline time 0 and up to 16 weeks
Health Survey Questionnaire short form 36
Time frame: Baseline time 0 and up to 16 weeks
Modified Ashworth Scale
Time frame: Baseline time 0 and up to 16 weeks
Modified "Tardieu" Scale
Time frame: Baseline time 0 and up to 16 weeks
Body's Centre of Pressure length (mm)
Time frame: Baseline time 0 and up to 16 weeks
Body's Centre of Pressure Area Path (mm2)
Time frame: Baseline time 0 and up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- 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.
Nicola Nicola, MD principal investigator
Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward Walking Treadmill Training and Treadmill Training in people with Stroke, run by Universita di Verona at 1 site in Italy.
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 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2016. 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 Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Picelli, MD (+39 045 8124573, alessandro.picelli@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meters Walking test (10-MtWT) change in gait speed (time frame: Baseline time 0 and up to 16 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 7 Sep 2016.