Long-term Exercise Effects from Robotic Walking

NCT04307602 | Active Not Recruiting

• 4 other identifiers: LU2019LEER2018-024332019-001062022-00729
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Physical Activity; Physical Fitness; Physical Exertion; Health

Outcome Measures

Primary Outcomes (1)

• Brain derived neurotropic factor (BDNF)

  12 months

Secondary Outcomes (2)

• Nerve growth factor (NGF)

  12 months

• Vascular endothelial growth factor (VEGF)

  12 months

Study Arms (3)

Children with cerebral palsy GMFCS IV-V

EXPERIMENTAL

Exercise intervention in the waling aide Innowalk

Other: Exercise - High Intensity Interval Training (HIIT); Other: Exercise - Submaximal Steady State Training (SST)

Children with cerebral palsy GMFCS I-II

ACTIVE COMPARATOR

Exercise intervention on spinning bikes

Other: Exercise - High Intensity Interval Training (HIIT); Other: Exercise - Submaximal Steady State Training (SST)

Children without disabilities

ACTIVE COMPARATOR

Exercise intervention on spinning bikes

Other: Exercise - High Intensity Interval Training (HIIT); Other: Exercise - Submaximal Steady State Training (SST)

Interventions

Exercise - High Intensity Interval Training (HIIT) OTHER

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

Children with cerebral palsy GMFCS I-II; Children with cerebral palsy GMFCS IV-V; Children without disabilities

Exercise - Submaximal Steady State Training (SST) OTHER

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 with cerebral palsy GMFCS I-II; Children with cerebral palsy GMFCS IV-V; Children without disabilities

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• non-ambulatory children with CP defined as GMFCS-E\&R IV-V, ambulatory children with CP defined as GMFCS-E\&R I-II and healthy controls: non-disabled children not participating in any regular and planned physical exercise.

You may not qualify if:

• Ambulatory children with CP walking with a walking aid (GMFCS-E\&R III); non-disabled children with other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairments or indigestion of regular medication.

Sponsors & Collaborators

• Lund University: lead
• The Swedish Research Council: collaborator
• Region Skane: collaborator
• Halmstad University: collaborator

Study Sites (1)

Health Sciences Centre

Lund, Skåne County, 221 00, Sweden

Location

MeSH Terms

Conditions

Motor Activity; Cerebral Palsy

Condition Hierarchy (Ancestors)

Behavior; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 13, 2020
• Study Start: May 1, 2019
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)