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

Cerebral Palsy Clinical Trial

— CP-Flywheel  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03124628
• Other study ID #: Flywheel CP
• Secondary ID: 16037
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 2018

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Flywheel resistance exercise
Flywheel resistance exercise, originally designed to maintain function, size and quality of skeletal muscle during spaceflight, employs iso-inertial technology rather than gravity dependent weights, which allows for coupled accommodated concentric and eccentric muscle actions, and brief episodes of eccentric overload.
• Weight-stack resistance exercise
Conventional weight-stack resistance exercise

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle performance	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.	Change from pre- to post-intervention (8 wks)
Primary	Muscle architecture	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.	Change from pre- to post-intervention (8 wks)
Primary	Electromyography of lower limb muscles	Muscle activation (mV) will be assessed in lower limb muscles (i.e. vastus lateralis, biceps femoris, gluteus medius, medial gastrocnemius) using surface electromyography techniques	Change from pre- to post-intervention (8 wks)
Primary	Assessment of activities of daily living	Assessment of activities of daily living is measured using the Timed Up-and-Go test, the Chair-stand and the 6-min walking test.	Change from pre- to post-intervention (8 wks)
Primary	Gait performance adaptations to training including muscle activation and co-contraction during walking	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	Change from pre- to post-intervention (8 wks)
Primary	Gross motor function	Gross motor function will be assessed using Gross Motor Function Measure (GMFM)	Change from pre- to post-intervention (8 wks)
Primary	Balance	Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital	Change from pre- to post-intervention (8 wks)
Primary	Muscle spasticity	Spasticity will be assessed using the Ashworth scale	Change from pre- to post-intervention (8 wks)
Secondary	Subcutaneous fat thickness	Subcutaneous fat thickness of the thigh of both legs will be assess using ultrasound techniques	Change from pre- to post-intervention (8 wks)