NCT03701035

Brief Summary

The aim of this study is to evaluate the influence on three different training modalities on the blood concentration levels of a growth factor called Brain Derived Neurotrophic Factor (BDNF) and on the recovery of arm function following in sub-acute and chronic stroke survivors. The training modalities are 1. moderate intensity aerobic training on a bike ergonometer followed by robotic or sensor-based upper-limb training, 2. non-aerobic circuit training followed by robotic or sensor-based upper-limb training 3. circuit training alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2018

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

October 7, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

October 7, 2018

Last Update Submit

December 28, 2022

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • BDNF

    Acute (immediate post exercise) and chronic (post-intervention) serum BDNF levels

    12 weeks

  • Action Research Arm Test (ARAT)

    A 19-Item standardised assessment of UL function measuring ADLs, coordination \& dexterity.

    12 weeks

Secondary Outcomes (7)

  • The Fugl-Meyer Assessment - Upper Extremity Scale (FMA).

    12 weeks

  • 10 meter walking test

    12 weeks

  • Trunk Sway in standing with eyes closed

    12 weeks

  • The Montreal Cognitive Assessment (MoCA©).

    12 weeks

  • Corsi Block Test

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Aerobic Training & UL Motor Training

EXPERIMENTAL

Aerobic training at 40%-59% Heart Rate Reserve (AT) increasing from personal maximum time (if \< 40 mins) to 40 minutes followed by UL motor training with the Armeo®Spring/Senso/Pablo X2® 3 \* weekly, 12 weeks

Behavioral: Aerobic Training & UL Motor Training

Non-aerobic Training & UL Motor Training

ACTIVE COMPARATOR

40 minutes non-aerobic gait \& balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2® 3 \* weekly, 12 weeks

Behavioral: Non-aerobic training & UL Motor Training

Interventions

Aerobic Training & UL Motor TrainingBEHAVIORAL

Aerobic training at 40%-59% Heart Rate Reserve (AT) increasing from personal maximum time (if \< 40 mins) to 40 minutes followed by UL motor training with the Armeo®Spring/Senso/Pablo X2®

Aerobic Training & UL Motor Training
Non-aerobic training & UL Motor TrainingBEHAVIORAL

40 minutes non-aerobic gait \& balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2®

Non-aerobic Training & UL Motor Training

Eligibility Criteria

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

You may qualify if:

  • Hemiplegic stroke ischemic or intracerebral hemorrhagic \> 3 months post- stroke
  • Active shoulder abduction, wrist and finger extension 10 degrees from a flexed position

You may not qualify if:

  • Contraindications to maximal exercise testing according to the American College of Sports Medicine guidelines
  • Severe perceptual problems
  • Concurrent neurological diagnoses e.g. Parkinsons disease
  • Comorbidities which may interfere with exercise participation
  • Significant cognitive impairment \< 24 on the Montreal Cognitive Assessment Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RehaB clinic for Neurorehabilitation and Paraplegiology

Basel, 4055, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Clare Maguire, PhD

    Bern University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Master Programme Neurorehabilitation

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 9, 2018

Study Start

October 8, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

CH(1)