Cerebral PalsyCP-FlywheelNCT03124628
Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
A study testing Flywheel resistance exercise and Weight-stack resistance exercise in people with Cerebral Palsy, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Flywheel resistance exercise and Weight-stack resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2017to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Surgical treatments of the knee extensor apparatus within the last 12 months
- Botulinum toxin treatment within the last six months
- Ongoing intrathecal baclofen treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
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
Read more
- To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.
- To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.
- 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).
- Conditions
- Cerebral Palsy
- Being tested
- Flywheel resistance exercise, Weight-stack resistance exercise
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flywheel resistance exerciseOther
Also called Yo-Yo technology
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 exerciseOther
Also called Conventional resistance exercise
Conventional weight-stack resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Flywheel resistance exercise | Experimental | 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. Receives: Other: Flywheel resistance exercise |
| Weight-stack resistance exercise | Active comparator | 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. Receives: Other: Weight-stack resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre- to post-intervention (8 wks)
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.
Measured: Change from pre- to post-intervention (8 wks)
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
Measured: Change from pre- to post-intervention (8 wks)
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.
Measured: Change from pre- to post-intervention (8 wks)
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
Measured: Change from pre- to post-intervention (8 wks)
Gross motor function
Gross motor function will be assessed using Gross Motor Function Measure (GMFM)
Measured: Change from pre- to post-intervention (8 wks)
Balance
Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital
Measured: Change from pre- to post-intervention (8 wks)
Muscle spasticity
Spasticity will be assessed using the Ashworth scale
Measured: Change from pre- to post-intervention (8 wks)
Secondary outcomes (1)
Subcutaneous fat thickness
Subcutaneous fat thickness of the thigh of both legs will be assess using ultrasound techniques
Measured: Change from pre- to post-intervention (8 wks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Mar 2017
- Primary completionSep 2017 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Fernandez Gonzalo, Karolinska Institutet
- Investigators
- Eva Pontén, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124628
- Sponsor's protocol ID
- Flywheel CP
- Other IDs
- 16037
- Acronym
- CP-Flywheel
- Status last verified
- Sep 2020
- First submitted
- 17 Mar 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03124628
- Acronym / sponsor ID
- CP-Flywheel / Flywheel CP
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.
- To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flywheel resistance exercise | Experimental | Other: Flywheel resistance exerciseDuring 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. |
| Weight-stack resistance exercise | Active comparator | Other: Weight-stack resistance exerciseDuring 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. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Surgical treatments of the knee extensor apparatus within the last 12 months
- Botulinum toxin treatment within the last six months
- Ongoing intrathecal baclofen treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flywheel resistance exerciseAlso: Yo-Yo technologyFlywheel 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 | Flywheel resistance exercise |
| Weight-stack resistance exerciseAlso: Conventional resistance exerciseConventional weight-stack resistance exercise | Other | Weight-stack resistance exercise |
Primary outcome
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
1 secondary outcome
Subcutaneous fat thickness
Time frame: Change from pre- to post-intervention (8 wks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Pontén, MD, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flywheel resistance exercise and Weight-stack resistance exercise in people with Cerebral Palsy, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle performance (time frame: Change from pre- to post-intervention (8 wks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.