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The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability (FAT-GAIT)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Muscle Spasticity
Paralysis; Cerebral

Treatments

Other: Fatigability assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT06163950
2022-A02510-43 (Other Identifier)
22CH527

Details and patient eligibility

About

Due to an early brain injury occurring in antenatal or postnatal, cerebral palsy (CP) causes alteration in motor function with posture and gait disorders. It is commonly observed motor performance degradation during adulthood, and the underlying pathophysiology remains poorly known.

Full description

One of the hypotheses to explain the decline in walking capacities in adults with CP is their greater fatigability, that could be related to energy overconsumption (due to the specific biomechanical constraints of their walking pattern) and/or the occurrence of early sarcopenia affecting the compensatory muscle mechanisms commonly seen in children to compensate for architectural disorders and posture alterations. To optimize prevention and/or therapy in these patients, it is crucial to better understand the aetiology of fatigability and its role in the decline in walking performance.

Enrollment

30 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Common for CP and healthy volunteers:

  • Capable of walking for six minutes without stopping
  • Capable of consenting to the tests

Specific for the CP group

  • GMFCS I or II at age 18
  • Spastic diplegic cerebral palsy

Exclusion criteria

  • Counter-indications to the test procedures
  • Mental retardation or intelligence quotient (IQ) below 80
  • Accompanying diseases not allowing for the test setup
  • Major surgeries altering performance in the last six months
  • Injection of botulin altering maximal force production in the last three months
  • Refusing to sign the consent form

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Patients with cerebral palsy
Experimental group
Description:
A specially adapted recumbent cycle ergometer with the ability to quickly transform into an isometric dynamometer will be used to assess fatigability development during a task to failure. Throughout the task, which consists of blocks of 3 minutes, neuromuscular assessments will take place to determine the evolution of fatigability and its peripheral and central determinants.
Treatment:
Other: Fatigability assessment
Healthy people
Active Comparator group
Description:
A specially adapted recumbent cycle ergometer with the ability to quickly transform into an isometric dynamometer will be used to assess fatigability development during a task to failure. Throughout the task, which consists of blocks of 3 minutes, neuromuscular assessments will take place to determine the evolution of fatigability and its peripheral and central determinants.
Treatment:
Other: Fatigability assessment

Trial contacts and locations

1

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Central trial contact

DIANA RIMAUD, PhD; Bruno FERNANDEZ, MD

Data sourced from clinicaltrials.gov

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