Clinical trial NCT03124628: Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
Official title: Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of this project is to improve physical function and muscle health in teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance exercise model

Specific aims

1. To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.
2. To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.
3. To improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy.

We hypothesize that the time-effective flywheel resistance exercise paradigm will result in greater gains in muscle mass and function in teenagers with CP, when compared with conventional weight-stack technology. Importantly, we believe these adaptations will be translated into enhanced gross motor function, balance and gait performance.

Forty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients will perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag, co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of lower extremities are assessed in all patients before and after the 8-week intervention (Fig. 1).


Eligibility criteria: Inclusion Criteria:

* Teenagers and young adults between 16-25 years of age
* Unilateral or bilateral spastic cerebral palsy
* Gross Motor Function Classification System (GMFCS) of level I, II or III.

Exclusion Criteria

* Surgical treatments of the knee extensor apparatus within the last 12 months
* Botulinum toxin treatment within the last six months
* Ongoing intrathecal baclofen treatment

Primary outcomes:
measure: Muscle performance
timeFrame: Change from pre- to post-intervention (8 wks)
measure: Muscle architecture
timeFrame: Change from pre- to post-intervention (8 wks)
measure: Electromyography of lower limb muscles
timeFrame: Change from pre- to post-intervention (8 wks)
measure: Assessment of activities of daily living
timeFrame: Change from pre- to post-intervention (8 wks)
measure: Gait performance adaptations to training including muscle activation and co-contraction during walking
timeFrame: Change from pre- to post-intervention (8 wks)
measure: Gross motor function
timeFrame: Change from pre- to post-intervention (8 wks)
measure: Balance
timeFrame: Change from pre- to post-intervention (8 wks)
measure: Muscle spasticity
timeFrame: Change from pre- to post-intervention (8 wks)
Secondary outcomes:
measure: Subcutaneous fat thickness
timeFrame: Change from pre- to post-intervention (8 wks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Eva Pontén, MD, PhD
role: STUDY_DIRECTOR
References: