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

• ClinicalTrials.gov Identifier: NCT03124628
• Recruitment Status: Withdrawn
• First Posted: April 24, 2017
• Last Update Posted: September 2, 2020
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Rodrigo Fernandez Gonzalo, Karolinska Institutet

Tracking Information

• First Submitted Date: March 17, 2017
• First Posted Date: April 24, 2017
• Last Update Posted Date: September 2, 2020
• Actual Study Start Date: March 1, 2017
• Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2017)

• 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.
• 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 spasticity [ Time Frame: Change from pre- to post-intervention (8 wks) ]
  Spasticity will be assessed using the Ashworth scale

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 18, 2017)

Subcutaneous fat thickness [ Time Frame: Change from pre- to post-intervention (8 wks) ]

Subcutaneous fat thickness of the thigh of both legs will be assess using ultrasound techniques

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: 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.
  Other Name: Yo-Yo technology
• Other: Weight-stack resistance exercise
  Conventional weight-stack resistance exercise
  Other Name: Conventional resistance exercise

Study Arms

• Experimental: Flywheel resistance exercise
  During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform flywheel leg press resistance exercise twice per week.
  Intervention: Other: Flywheel resistance exercise
• Active Comparator: Weight-stack resistance exercise
  During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform conventional, weight-stack leg press resistance exercise twice per week.
  Intervention: Other: Weight-stack resistance exercise

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: September 1, 2020): 0
• Original Estimated Enrollment (submitted: April 18, 2017): 40
• Estimated Study Completion Date: March 2018
• Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 25 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03124628
• Other Study ID Numbers: Flywheel CP; 16037 ( Other Grant/Funding Number: Promobilia )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Rodrigo Fernandez Gonzalo, Karolinska Institutet
• Original Responsible Party: Same as current
• Current Study Sponsor: Karolinska Institutet
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Eva Pontén, MD, PhD; Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: September 2020