Clinical trial NCT02710773: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Gait
Randomized controlled trial
Chronic Stroke
Treadmill training
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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);

Primary outcomes:
measure: 10 meters Walking test (10-MtWT) change in gait speed
timeFrame: Baseline time 0 and up to 16 weeks
Secondary outcomes:
measure: Gait analysis
timeFrame: Baseline time 0 and up to 16 weeks
measure: Stroke Impact scale
timeFrame: Baseline time 0 and up to 16 weeks
measure: Health Survey Questionnaire short form 36
timeFrame: Baseline time 0 and up to 16 weeks
measure: Modified Ashworth Scale
timeFrame: Baseline time 0 and up to 16 weeks
measure: Modified "Tardieu" Scale
timeFrame: Baseline time 0 and up to 16 weeks
measure: Body's Centre of Pressure length (mm)
timeFrame: Baseline time 0 and up to 16 weeks
measure: Body's Centre of Pressure Area Path (mm2)
timeFrame: Baseline time 0 and up to 16 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
state: Italy, Verona
Study officials:
affiliation: Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy
name: Nicola Nicola, MD
role: PRINCIPAL_INVESTIGATOR
References: