Backward Treadmill Training in Patients With Chronic Stroke

NCT02710773 | Unknown DMC

• 1 other identifier: BWTreadmillSTROKE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Gait; Randomized controlled trial; Chronic Stroke; Treadmill training

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline time 0 and up to 16 weeks

Secondary Outcomes (7)

• Gait analysis

  Baseline time 0 and up to 16 weeks

• Stroke Impact scale

  Baseline time 0 and up to 16 weeks

• Health Survey Questionnaire short form 36

  Baseline time 0 and up to 16 weeks

• Modified Ashworth Scale

  Baseline time 0 and up to 16 weeks

• Modified "Tardieu" Scale

  Baseline time 0 and up to 16 weeks

Study Arms (2)

Backward Walking Treadmill Training

EXPERIMENTAL

The subjects will perform a backward walking training on treadmill device

Other: Backward Walking Treadmill Training

Treadmill training

ACTIVE COMPARATOR

The subjects will perform a walking training on treadmill device

Other: Treadmill Training

Interventions

Backward Walking Treadmill Training OTHER

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.

Backward Walking Treadmill Training

Treadmill Training OTHER

The intervention will consist of 20 minutes of forward walking on a treadmill device.

Treadmill training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Italy, Verona, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nicola Nicola, MD

  Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Picelli, MD

CONTACT

+39 045 8124573; alessandro.picelli@univr.it

Daniele Munari, PhD

CONTACT

+39 045 8124573; daniele.munari@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 17, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)