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Clinical Trials/NCT03124628
NCT03124628
Withdrawn
Not Applicable

Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy

Karolinska Institutet1 site in 1 countryMarch 1, 2017
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Karolinska Institutet
Locations
1
Primary Endpoint
Electromyography of lower limb muscles
Status
Withdrawn
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
March 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rodrigo Fernandez Gonzalo

PhD

Karolinska Institutet

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Electromyography of lower limb muscles

Time Frame: Change from pre- to post-intervention (8 wks)

Muscle activation (mV) will be assessed in lower limb muscles (i.e. vastus lateralis, biceps femoris, gluteus medius, medial gastrocnemius) using surface electromyography techniques

Assessment of activities of daily living

Time Frame: Change from pre- to post-intervention (8 wks)

Assessment of activities of daily living is measured using the Timed Up-and-Go test, the Chair-stand and the 6-min walking test.

Gait performance adaptations to training including muscle activation and co-contraction during walking

Time Frame: Change from pre- to post-intervention (8 wks)

Gait performance will be analyzed using an 8-camera 3-D kinematic VICON system and force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital. Overall gait pathology will also be assessed using the multivariate Gait Deviation Index. Muscle activation and co-contraction during gait will be assessed using wireless surface electromyography

Gross motor function

Time Frame: Change from pre- to post-intervention (8 wks)

Gross motor function will be assessed using Gross Motor Function Measure (GMFM)

Balance

Time Frame: Change from pre- to post-intervention (8 wks)

Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital

Muscle performance

Time Frame: Change from pre- to post-intervention (8 wks)

Unilateral maximal voluntary isometric force is measured in both legs with force sensors. Similarly, unilateral (both legs) concentric and eccentric peak power is assessed through an encoder system. Furthermore, dynamic force during concentric and eccentric actions is measured via force sensors.

Muscle architecture

Time Frame: Change from pre- to post-intervention (8 wks)

Vastus lateralis muscle thickness, together with fascicle pennation angle and muscle echogenicity, will be assessed using ultrasound technique in both legs. Thigh circumference will be assessed using measurement tape.

Muscle spasticity

Time Frame: Change from pre- to post-intervention (8 wks)

Spasticity will be assessed using the Ashworth scale

Secondary Outcomes

  • Subcutaneous fat thickness(Change from pre- to post-intervention (8 wks))

Study Sites (1)

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