Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke

Stroke Clinical Trial

Official title:

Energy Consumption and Cardiorespiratory Load During Overground Gait Training With a Wearable Exoskeleton After Stroke: the Effect of the Level of Swing Assistance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03367091
• Other study ID #: EKSO STUDY I
• Status: Terminated
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke

Description:

RESEARCH AIMS:

• To investigate the effect of the level of swing assistance on the acute metabolic and cardiorespiratory responses during overground gait training with a wearable exoskeleton in persons after stroke

• To investigate if there is an interaction-effect between the level of swing assistance and the duration of walking

• To compare the exercise intensity to aerobic training recommendations

STUDY DESIGN: An experimental, 1-group trial with randomized crossover design.

PATIENT RECRUITMENT: Participants will be recruited at the AZ Herentals (Herentals, Belgium).

LOCATION: The trial will be conducted at the REVAlution Center (Herentals, Belgium).

ELIGIBILITY CRITERIA: See section "Eligibility"

PROCEDURES: Before the start of the study, informed consent and baseline patient characteristics will be collected. Next, participants will be measured during three training sessions with the Ekso GT SmartAssist:

• 20-minute training with high swing assistance

• 20-minute training with neutral swing assistance

• 20-minute training with high swing resistance

Trainings will be performed on a separate day in a randomized order (within one week and controlled for time of day).

Following settings will be used in all three conditions: sitting program ("Min lean"); standing program ("Auto lean"); step initiation program ("ProStep+"), training mode ("Off"), SmartAssist option ("2Free"); and stance support ("Low"). The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side.

During training, participants will walk back and forth at a self-selected walking speed in a 30m hall way using a cane at the non-affected side.

Prior to the experimental conditions, participants will have had three training sessions in the Ekso GT.

RESTRICTIONS & PROHIBITIONS: Participants will be instructed to not consume food, alcohol, caffeine or nicotine at least 3h prior to the intervention. Usual medication intake will be allowed with small amounts of water.

MATERIALS: The Ekso GT robotic exoskeleton with SmartAssist (Ekso Bionics Inc., USA) will be used during the overground training sessions.

A flexible facemask (adult facemask, small/medium, Cortex, Germany), lightweight chest carrying gas analysis system (Metamax 3B, Cortex, Germany) and Bluetooth heart rate belt (Polar H7, Polar Electro, Finland) will be used to measure metabolic and cardiorespiratory parameters. At the start of each measurement, gas (room air and reference gas (17.4% O2 and 5.1% CO2)) and volume (3L syringe) calibrations of the breath-by-breath gas analysis system will be performed in accordance with the manufacturer's instructions.

OUTCOMES: See section "Outcome Measures"

DATA-ANALYSES: Descriptive statistics will be calculated for baseline patient characteristics. To investigate the effect of level of swing assistance and duration, a repeated measures ANOVA (within factor duration and within factor assistance level) will be conducted (interaction-effect time x duration, main effect assistance level and main effect duration). In case of significant differences, posthoc analyses will be interpreted. The walking speed will be considered as a covariate in the ANOVA analysis (in case significant different between conditions). Significance level will be set at 5%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Included will be persons who

• Had a stroke

• Cannot walk independently or can walk independently on level ground, but still require help on stairs, slopes or uneven surfaces (FAC 0 - 4)

Excluded will be persons who

• Can walk independently on level ground, stairs, slopes and uneven surfaces (FAC 5)

• Have musculoskeletal problems (other than stroke) affecting the ability to walk

• Have concurrent pulmonary diseases (e.g. asthma)

• Have unstable cardiovascular conditions

• Have concurrent neurological diseases (e.g. Parkinson's Disease)

• Have communicative and/or cognitive problems affecting the ability to understand or follow instructions

• Present contra-indications for using the Ekso GT (according to manufacturer's instructions)

• Severe concurrent medical diseases (infections, circulatory, heart or lung, pressure sores)

• Severe spasticity (Ashworth 4)

• Range of motion restrictions that would prevent a patient from achieving normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions

• Bilateral hip flexion < 110°

• Knee flexion contracture > 12°

• Inability to achieve 0° neutral angle dorsiflexion with knee flexion = 12°

• Weight = 100 kg

• Hip width < 35.8 cm or > 45.6 cm

• Upper leg length < 51 cm or > 61.4 cm

• Lower leg length < 48 cm or > 63.4 cm

• Upper leg length discrepancy > 0.5 inch (1.3 cm)

• Lower leg length discrepancy > 0.75 inch (1.9 cm)

• Unstable spine, unhealed limbs or pelvic fractures

• Unhealthy bone density

• Heterotopic ossification

• Significant contractures

• Elbows and shoulders are unable to support crutches, walker or cane

• Psychiatric or cognitive situations that may interfere with proper operation of the device

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Ekso GT gait training with high swing assistance
Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high assistance"
• Ekso GT gait training with neutral swing assistance
Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "neutral"
• Ekso GT gait training with high swing resistance
Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at "high resistance"

Locations

Country	Name	City	State
Belgium	REVAlution center	Herentals	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking speed (m/min) at minute 5 of walking	The distance (meters) walked per minute	Minute 5 of 20-minute walking period
Other	Walking speed (m/min) at minute 10 of walking	The distance (meters) walked per minute	Minute 10 of 20-minute walking period
Other	Walking speed (m/min) at minute 15 of walking	The distance (meters) walked per minute	Minute 15 of 20-minute walking period
Other	Walking speed (m/min) at minute 20 of walking	The distance (meters) walked per minute	Minute 20 of 20-minute walking period
Primary	Net oxygen cost (OC, ml/kg/m) at minute 5 of walking	Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)	Minute 5 of 20-minute walking period
Primary	Net oxygen cost (OC, ml/kg/m) at minute 10 of walking	Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)	Minute 10 of 20-minute walking period
Primary	Net oxygen cost (OC, ml/kg/m) at minute 15 of walking	Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)	Minute 15 of 20-minute walking period
Primary	Net oxygen cost (OC, ml/kg/m) at minute 20 of walking	Net oxygen consumption (oxygen consumption (ml/kg/min) during walking minus during rest) divided by the walking speed (m/min)	Minute 20 of 20-minute walking period
Primary	Net heart rate (HR, beats/min) at minute 5 of walking	Heart rate during walking (beats/min) minus resting heart rate	Minute 5 of 20-minute walking period
Primary	Net heart rate (HR, beats/min) at minute 10 of walking	Heart rate during walking (beats/min) minus resting heart rate	Minute 10 of 20-minute walking period
Primary	Net heart rate (HR, beats/min) at minute 15 of walking	Heart rate during walking (beats/min) minus resting heart rate	Minute 15 of 20-minute walking period
Primary	Net heart rate (HR, beats/min) at minute 20 of walking	Heart rate during walking (beats/min) minus resting heart rate	Minute 20 of 20-minute walking period
Primary	Net minute ventilation (VE, L/min) at minute 5 of walking	The amount of air in- or exhaled per minute (L/min) during walking minus during rest	Minute 5 of 20-minute walking period
Primary	Net minute ventilation (VE, L/min) at minute 10 of walking	The amount of air in- or exhaled per minute (L/min) during walking minus during rest	Minute 10 of 20-minute walking period
Primary	Net minute ventilation (VE, L/min) at minute 15 of walking	The amount of air in- or exhaled per minute (L/min) during walking minus during rest	Minute 15 of 20-minute walking period
Primary	Net minute ventilation (VE, L/min) at minute 20 of walking	The amount of air in- or exhaled per minute (L/min) during walking minus during rest	Minute 20 of 20-minute walking period
Secondary	Net Rating of Perceived Exertion (RPE, 6-20) at minute 5 of walking	Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest	Minute 5 of 20-minute walking period
Secondary	Net Rating of Perceived Exertion (RPE, 6-20) at minute 10 of walking	Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest	Minute 10 of 20-minute walking period
Secondary	Net Rating of Perceived Exertion (RPE, 6-20) at minute 15 of walking	Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest	Minute 15 of 20-minute walking period
Secondary	Net Rating of Perceived Exertion (RPE, 6-20) at minute 20 of walking	Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) during walking minus during rest	Minute 20 of 20-minute walking period
Secondary	Percentage maximal heart rate (%HRmax) at minute 5 of walking	Heart rate divided by predicted maximum heart rate.	Minute 5 of 20-minute walking period
Secondary	Percentage maximal heart rate (%HRmax) at minute 10 of walking	Heart rate divided by predicted maximum heart rate.	Minute 10 of 20-minute walking period
Secondary	Percentage maximal heart rate (%HRmax) at minute 15 of walking	Heart rate divided by predicted maximum heart rate.	Minute 15 of 20-minute walking period
Secondary	Percentage maximal heart rate (%HRmax) at minute 20 of walking	Heart rate divided by predicted maximum heart rate.	Minute 20 of 20-minute walking period
Secondary	Percentage heart rate reserve (%HRR) at minute 5 of walking	Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)	Minute 5 of 20-minute walking period
Secondary	Percentage heart rate reserve (%HRR) at minute 10 of walking	Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)	Minute 10 of 20-minute walking period
Secondary	Percentage heart rate reserve (%HRR) at minute 15 of walking	Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)	Minute 15 of 20-minute walking period
Secondary	Percentage heart rate reserve (%HRR) at minute 20 of walking	Heart rate during walking minus during rest divided by predicted heart rate reserve (i.e. predicted maximum heart rate minus resting heart rate)	Minute 20 of 20-minute walking period
Secondary	Metabolic Equivalent of Task (MET) at minute 5 of walking	Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest	Minute 5 of 20-minute walking period
Secondary	Metabolic Equivalent of Task (MET) at minute 10 of walking	Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest	Minute 10 of 20-minute walking period
Secondary	Metabolic Equivalent of Task (MET) at minute 15 of walking	Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest	Minute 15 of 20-minute walking period
Secondary	Metabolic Equivalent of Task (MET) at minute 20 of walking	Expression of the intensity of walking defined as the oxygen consumption (ml/kg/min) during walking divided by the oxygen consumption (ml/kg/min) in rest	Minute 20 of 20-minute walking period