Spastic Cerebral PalsySCPSLACKNCT03486483
Spastic Cerebral Palsy and Slackline
A study testing Exercise in people with Spastic Cerebral Palsy, run by Luis Santos.
Trial summary
The aim of the present study was to assess whether supervised slackline training improves postural control in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 15 May 2016
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis with any expression of spastic cerebral palsy and rated I-II on the Gross Motor Functional classification.
- Between 9 and 16 years of age.
- Ability to cooperate with simple instructions.
- Able to stand for at least 2 min without assistance.
- Able to walk at least 10 m without assistance.
Who cannot join
- Individuals were excluded if they underwent neuro or orto surgery during or up to one year prior to the study, botulinum toxin injection or intrathecal pump during or up to six months prior to the study and/or rotational osteotomies, if they expressed gait deviations limited by musculoskeletal contracture, presented specific medical or orthopedic conditions that precluded exercising
- or if they did not meet the eligibility criteria.
About this study
Official title: The Slackline as a Rehabilitation Tool for Children and Teenagers With Spastic Cerebral Palsy: a Randomised Clinical Trial
The aim of the present study was to assess whether supervised slackline training improves postural control in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System).
- Conditions
- Spastic Cerebral Palsy
- Being tested
- 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.
ExerciseOther
Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Slackline Training | Experimental | Supervised Slackline training in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System). Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one. Receives: Other: Exercise |
| Physical Activity | No intervention | The control group followed its usual weekly physical activity routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static posturography (a composite measure).
The centre of pressure (CoP) parameters (these CoP parameters; Length, Xmean, Ymean, Xdeviation and Ydeviation in mm, Area in mm2 and Speed, Xspeed and Yspeed in m/s will be combined to report the static posturography).
Measured: 6 weeks.
Secondary outcomes (2)
Myoelectrical activity.
Soles, Tibialis Anterior and Peroneus Longus (myoelectrical activity in microvolts).
Measured: 6 weeks.
Jump Performance
Countermovement Jump Test and Abalakov´s Test (jump height in cm).
Measured: 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Apr 2015
- Primary completion1 Apr 2015
- Study completion15 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luis Santos, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486483
- Sponsor's protocol ID
- No. 53/2014
- Acronym
- SCPSLACK
- Status last verified
- Mar 2018
- First submitted
- 18 Mar 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Slackline as a Rehabilitation Tool for Children and Teenagers With Spastic Cerebral Palsy: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03486483
- Acronym / sponsor ID
- SCPSLACK / No. 53/2014
- Conditions
- Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Luis SantosUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 15 May 2016 (actual)
- First posted
- 3 Apr 2018 (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 aim of the present study was to assess whether supervised slackline training improves postural control in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Slackline Training | Experimental | Other: ExerciseSupervised Slackline training in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System). Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one. |
| Physical Activity | No intervention | –The control group followed its usual weekly physical activity routine. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis with any expression of spastic cerebral palsy and rated I-II on the Gross Motor Functional classification.
- Between 9 and 16 years of age.
- Ability to cooperate with simple instructions.
- Able to stand for at least 2 min without assistance.
- Able to walk at least 10 m without assistance.
Key exclusion criteria (2 listed)
- Individuals were excluded if they underwent neuro or orto surgery during or up to one year prior to the study, botulinum toxin injection or intrathecal pump during or up to six months prior to the study and/or rotational osteotomies, if they expressed gait deviations limited by musculoskeletal contracture, presented specific medical or orthopedic conditions that precluded exercising
- or if they did not meet the eligibility criteria.
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 |
|---|---|---|
| ExerciseIntervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one. | Other | Supervised Slackline Training |
Primary outcome
Static posturography (a composite measure).
Time frame: 6 weeks.
The centre of pressure (CoP) parameters (these CoP parameters; Length, Xmean, Ymean, Xdeviation and Ydeviation in mm, Area in mm2 and Speed, Xspeed and Yspeed in m/s will be combined to report the static posturography).
2 secondary outcomes
Myoelectrical activity.
Time frame: 6 weeks.
Jump Performance
Time frame: 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Spastic Cerebral Palsy, run by Luis Santos.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Static posturography (a composite measure). (time frame: 6 weeks.). 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 4 Apr 2018.