Backward Treadmill Training in Patients With Chronic Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Backward Walking Treadmill Training
Treadmill Training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Gait, Randomized controlled trial, Chronic Stroke, Treadmill training
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- Complex ventricular arrhythmia;
- Resting systolic blood pressure >200 mm/Hg - Resting diastolic blood pressure >100 mm/Hg;
- Aphasia (unable to follow two commands);
Sites / Locations
- Azienta Ospedaliera, SSO Rehabilitation Unit, VeronaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Backward Walking Treadmill Training
Treadmill training
Arm Description
The subjects will perform a backward walking training on treadmill device
The subjects will perform a walking training on treadmill device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Modified Ashworth Scale
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
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)
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)
Full Information
NCT ID
NCT02710773
First Posted
February 23, 2016
Last Updated
September 6, 2016
Sponsor
Universita di Verona
1. Study Identification
Unique Protocol Identification Number
NCT02710773
Brief Title
Backward Treadmill Training in Patients With Chronic Stroke
Official Title
Effects of Backward Treadmill Training on Spasticity and Gait Ability in Patients With Chronic Stroke: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Gait, Randomized controlled trial, Chronic Stroke, Treadmill training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Backward Walking Treadmill Training
Arm Type
Experimental
Arm Description
The subjects will perform a backward walking training on treadmill device
Arm Title
Treadmill training
Arm Type
Active Comparator
Arm Description
The subjects will perform a walking training on treadmill device
Intervention Type
Other
Intervention Name(s)
Backward Walking Treadmill Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill Training
Intervention Description
The intervention will consist of 20 minutes of forward walking on a treadmill device.
Primary Outcome Measure Information:
Title
10 meters Walking test (10-MtWT) change in gait speed
Description
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.
Time Frame
Baseline time 0 and up to 16 weeks
Secondary Outcome Measure Information:
Title
Gait analysis
Description
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.
Time Frame
Baseline time 0 and up to 16 weeks
Title
Stroke Impact scale
Description
this 64-item questionnaire is self- administered, with each item scored on a 5-point Likert scale, and assesses 8 domains of stroke.
Time Frame
Baseline time 0 and up to 16 weeks
Title
Health Survey Questionnaire short form 36
Description
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.
Time Frame
Baseline time 0 and up to 16 weeks
Title
Modified Ashworth Scale
Time Frame
Baseline time 0 and up to 16 weeks
Title
Modified "Tardieu" Scale
Description
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
Time Frame
Baseline time 0 and up to 16 weeks
Title
Body's Centre of Pressure length (mm)
Description
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)
Time Frame
Baseline time 0 and up to 16 weeks
Title
Body's Centre of Pressure Area Path (mm2)
Description
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)
Time Frame
Baseline time 0 and up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
Complex ventricular arrhythmia;
Resting systolic blood pressure >200 mm/Hg - Resting diastolic blood pressure >100 mm/Hg;
Aphasia (unable to follow two commands);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Picelli, MD
Phone
+39 045 8124573
Email
alessandro.picelli@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Munari, PhD
Phone
+39 045 8124573
Email
daniele.munari@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Nicola, MD
Organizational Affiliation
Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
City
Verona
State/Province
Italy, Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Smania
Phone
+39 0458124573
Email
nicola.smania@univr.it
First Name & Middle Initial & Last Name & Degree
Daniele Munari
Phone
+39 0458124573
Email
daniele.munari@univr.it
First Name & Middle Initial & Last Name & Degree
Nicola Smania Nicola Smania
12. IPD Sharing Statement
Plan to Share IPD
No
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Backward Treadmill Training in Patients With Chronic Stroke
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