Stroke Clinical Trial
Official title:
The Acute Effect of Using a Bionic Leg on Physiological Cost Index and Biomechanical Measures in Chronic Stroke Patients
Verified date | October 2018 |
Source | University of Winchester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the effect of wearing a wearable bionic leg, on the physiological cost index and biomechanical measures in patients with stroke. Patients will be tested during a range of activities (sit-to-stand, walking) with and without the Bionic Leg, and following a 30-min training program.
Status | Completed |
Enrollment | 9 |
Est. completion date | October 8, 2018 |
Est. primary completion date | October 8, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with a diagnosis of stroke within 3 months to 5 years of study start date. - Community patients who are medically stable and are either (1) currently receiving physical therapy from a neurophysiotherapy practice or (2) attending a community-based stroke support group and do not actively receive physical therapy. - Individuals who are able to stand and step with an aid or assistance - Patients who are cognitively aware to undertake rehabilitation exercises, physical therapy and activity. - Patients whose height is 1.58-1.92m - Patients whose weight is less than 159kg. Exclusion Criteria: - Unresolved deep-vein thrombosis - Unstable cardiovascular conditions - Open wounds - Active drug resistant infections - Recent fractures of involved limb - Peripheral arterial disease - Incontinence - Severe osteoporosis - Non-weight bearing |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Sport | Winchester | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Winchester | University College Dublin |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Physiological Cost Index between baseline and follow-up | Physiological Cost Index is a measure of energy expenditure. The Physiological Cost Index is collected from a 3-min walking test. Prior to the test, participants remain seated for 5-mins so a resting heart rate can be recorded. It is anticipated the resting heart rate will be between 40 and 80 beats per minute. Lower heart rates are considered better than higher heart rates at rest. Thereafter, participants will walk for 3 minutes at a self-selected walking pace. Heart rate will be recorded throughout. It is anticipated that the heart rate at the end of 3 minutes will be between 80 and 120 beats per minute. Lower heart rates will be seen to be better than higher heart rates. Physiological Cost Index is calculated by (Heart rate during steady state exercise - heart rate at rest)/walking speed. The smaller change in heart rate between rest and the end of the 3 minute test, the better the Physiological Cost Index. | Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline) | |
Secondary | Change in Timed-Up-and-Go between baseline and follow-up | A BTS G-walk system will be used to collect Timed-Up-and-Go data. From a seated position, participants will stand, walk to a cone 3 m away, walk around the cone, and walk back to the chair and sit back down. Participants will complete 2 familiarization trials prior to the actual test itself. A minimum of 3 trials will be performed. | Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline) | |
Secondary | Change in Postural Sway between baseline and follow-up | Postural sway parameters of maximal anterior-posterior and mediolateral sway will be calculated on the basis of the center of pressure. Time series will be acquired by means of a pressure mat mounted on top of a Kistler force platform (Kistler,Winterthur, Switzerland). Participants will stand on the pressure mat, unaided if possible, and trials will consist of eyes open, shoes on; eyes closed, shoes on; eyes open, shoes off; and eyes closed, shoes off. A minimum of 3 trials will be performed for each condition, each lasting 10 s. Participants will complete this test either or with or without the Bionic Leg | Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline) | |
Secondary | Change in Gait analysis between baseline and follow-up | The participants will be asked to walk for 6 m, over a pressure mat (RSscan Footscan, Ipswitch, UK), for a minimum of 3 trials in order to obtain walking gait patterns. A BTS G-Walk (Brooklyn, NewYork) sensor will also be worn by the participants to collect additional spatiotemporal gait parameters (cadence, speed, stride/step length, stance/swing phase duration, single/double support duration, and pelvic girdle angles). Participants will complete this test either or with or without the Bionic Leg | Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Post-Training Program Assessment | |
Secondary | Change in 6-min walk test between baseline and follow-up | Participants will walk around two cones placed 9 m apart. Participants will walk as far as possible in 6 minutes. Participants will complete this test either or with or without the Bionic Leg. | Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline) | |
Secondary | Change in Sit-to-Stand between baseline and follow-up | 10 x sit-to-stand exercises will be performed on a pressure mat | Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline) |
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