Stroke Clinical Trial
Official title:
Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients
Verified date | February 2019 |
Source | Vrije Universiteit Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study will be to investigate the energy consumption, cardiorespiratory load
and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted
gait training (RAGT) session and to compare the exercise intensity with aerobic training
recommendations.
The second aim is to investigate the effect of different levels of guidance force on the
energy consumption, cardiorespiratory load and perceived exertion.
Status | Completed |
Enrollment | 12 |
Est. completion date | January 8, 2019 |
Est. primary completion date | January 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - First-ever subacute (= 3 months) stroke patients - Eligible to receive robot-assisted gait training according to local therapists' criteria (i.e. non-ambulatory stroke patients that are able to bear full weight on the hemiplegic leg during a minimum of one gait cycle with manual help allowed to maintain balance) - Functional Ambulation Category < 3 - Trained in the Lokomat system 2 times prior to the start of the study (i.e. one fitting session and one training session). Exclusion Criteria: - > 135 kg and >179 cm - Unstable cardiovascular conditions - Musculoskeletal problems (other than stroke) affecting the ability to walk - Concurrent pulmonary diseases (e.g. asthma) - Concurrent neurological diseases - Communicative and/or cognitive problems affecting the ability to comprehend or follow instructions - Other problems affecting the execution of the intervention (e.g. severe spasticity, contractures or dermatological contra-indications) |
Country | Name | City | State |
---|---|---|---|
Belgium | St. Ursula Rehabilitation Centre (Jessa Hospital) | Herk-de-Stad | Limburg |
Lead Sponsor | Collaborator |
---|---|
Vrije Universiteit Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygen consumption (VO2) | Average oxygen consumption (mL/kg/min) at different time frames. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards. | End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) | |
Primary | Carbon Dioxide Production (CO2) | Average carbon dioxide production (mL/kg/min) at different time frames. Carbon dioxide production will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards. | End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) | |
Primary | Minute ventilation (VE) | Average amount of air in- or exhaled (L/min) at different time frames. VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards. | End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) | |
Primary | Heart rate (HR) | Average heart rate (beats/min) at different time frames. Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards. | End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) | |
Primary | Percentage heart rate reserve (%HRR) | The percentage of the heart rate reserve (i.e. the difference between the person's predicted maximum heart rate and the person's resting heart rate) at different time moments (= heart rate at different times moments divided by predicted heart rate reserve). | Begin, mid and end of 20min walking period (session 1) | |
Primary | Percentage maximal heart rate (%HRmax) | The percentage of the person's predicted maximal heart rate at different time moments (= heart rate at different times moments divided by predicted maximal heart rate). | Begin, mid and end of 20min walking period (session 1) | |
Primary | Rating of perceived exertion (assessed by the 6-20 Borg scale) (RPE) | Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) at the end of rest and during walking (every 3 minutes). | End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3) |
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