NCT02995616

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 16, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

December 13, 2016

Last Update Submit

February 5, 2019

Conditions

Stroke

Keywords

Robot-Assisted Gait TrainingGuidance forceStrokeEnergy ConsumptionCardiorespiratory Load

Outcome Measures

Primary Outcomes (7)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (1)

Lokomat training

EXPERIMENTAL

Patients will be tested in 3 Lokomat training sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (100% guidance force and 60% guidance force).

Device: Regular therapy settingsDevice: 100% guidance forceDevice: 60% guidance force

Interventions

Regular therapy settingsDEVICE

Patients will walk in the Lokomat according to their regular therapy settings for a minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body weight support (BWS) and maximum tolerable walking speed)

Lokomat training
100% guidance forceDEVICE

Patients will walk in the Lokomat with 100% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)

Lokomat training
60% guidance forceDEVICE

Patients will walk in the Lokomat with 60% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)

Lokomat training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \> 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Ursula Rehabilitation Centre (Jessa Hospital)

Herk-de-Stad, Limburg, 3540, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eric Kerckhofs, Prof. Ph.D

    Vrije Universiteit Brussel

    STUDY CHAIR

  • Eva Swinnen, Prof. Ph.D

    Vrije Universiteit Brussel

    STUDY DIRECTOR

  • Nina Lefeber, Ph.D student

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 16, 2016

Study Start

March 16, 2017

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

BE(1)