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Long-term Exercise Effects from Robotic Walking

NCT04307602 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-25

No results posted yet for this study

Summary

The vision of the Long-term Exercise Effects from Robotic Walking (LEER) research program is to develop optimal, individualized exercise strategies that would in turn enhance the health and well-being of non-ambulatory children with cerebral palsy (CP).

To date, it has not been possible to study exercise among non-ambulatory children with cerebral palsy in a structured and standardized manner. Improved possibilities to carry out such studies are now offered by the robotic medical device Innowalk, which allows various training options in an upright weight-bearing position. In order to design optimal exercise strategies for children with cerebral palsy, the investigators will examine the effects of two tailored training programs, using Innowalk. Changes in cardiopulmonary and metabolic parameters, and in the levels of brain derived neurotropic factor (BDNF), nerve growth factor (NGF) and vascular endothelial growth factor (VEGF) will be examined.

The investigators will assess the acute (1 day), adaptive (16 weeks), and long-term (1 year) effects of the exercise programs through indirect calorimetry and blood samples at multiple time points. The investigators will also study the environmental and behavioral factors facilitating and hindering participation in exercise, by semi-structured interviews.

The goal is to design improved individualized exercise programs that will increase health and well-being in the children and their families, thereby decreasing the use of medications and healthcare.

Conditions

  • Exercise
  • Children
  • Cerebral Palsy

Interventions

OTHER

Exercise - High Intensity Interval Training (HIIT)

Exercise in the walk aid Innowalk for children for children with CP GMFCS IV-V, Exercise on spinning bike for children with CP GMFCS I-II and non-disabled children

OTHER

Exercise - Submaximal Steady State Training (SST)

Exercise in the walk aid Innowalk for children for children with CP GMFCS IV-V, Exercise on spinning bike for children with CP GMFCS I-II and non-disabled

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Region Skane

    collaborator OTHER

  • Halmstad University

    collaborator OTHER

  • Lund University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2025-06-30
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307602 on ClinicalTrials.gov