Electrical stimulation cycling exercise in persons with cerebral palsy

Not Applicable

Recruiting

• Conditions: cerebral palsy; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12616000744459
• Lead Sponsor: Dr Che Fornusek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

The inclusion criteria for participants are:
1) 13-18 years old
2) The diagnosis of Cerebral Palsy
3) GMFCS Level III (uses an assistive mobility device or a wheelchair for long distances)
4) Sufficient covering of the femoral head in the acetabulum (MIGR% < 40%) and no significant scoliosis (primary curve >40 degrees).
5) Absence of severe tactile hypersensitivity in the lower extremities
6) Visuoperceptual skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
7) The ability to maintain an upright position with minimal support and to sit in a wheelchair for approximately one hour.
8) Have adequate passive range of motion of the hips, knees and ankle to complete a full revolution of the cycle ergometer.
9) Ability to communicate pain or discomfort directly with the researcher or indirectly via a carer to participate in cycling trials (Communication Function Classification System less than or equal to 3)
10) The willingness to participate in two training sessions per week for 8 weeks lasting approximately 1 hour each session (approximately 15 min of set up and up to 45 minutes of training) and to complete 2-3 days of testing during each assessment period (baseline, post testing).
11) The ability to gain consent from participant and parent/guardian

Exclusion Criteria

Exclusion criteria are:
1) Lower extremity joint pain during cycling
2) Spinal fusion that extends to the pelvis
3) Hip, knee, or ankle joint instability or dislocation
4) History of lower limb stress fractures in the past year
5) Pulmonary disease limiting exercise tolerance
6) Symptomatic or known cardiac disease
7) Unhealed wounds or pressure sores
8) Muscles that are non-responsive to electrical stimulation
9) History of surgery or traumatic fracture to the lower extremities within the past year
10) Botox injections to the lower extremity muscles within the past 6 months.
11) Severe spasticity in legs (score of 4 on the Modified Ashworth scale)
12) Severely limited range of joint motion/irreversible muscle contractures that prevent the subject from being able to be safely positioned on the cycle.
13) Presence of an uncontrolled seizure disorder
14) Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence will be evaluated by average percentage of sessions and amount of training time completed in the 8 week training program. Reasons for absences from training will be recorded. [Immediately post the exercise intervention (8 weeks)]