Spastic Cerebral Palsy and Slackline (SCPSLACK)

April 2, 2018 updated by: Luis Santos

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Slackline Training
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.
Other: Exercise
Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.
No Intervention: Physical Activity
The control group followed its usual weekly physical activity routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myoelectrical activity.
Time Frame: 6 weeks.
Soles, Tibialis Anterior and Peroneus Longus (myoelectrical activity in microvolts).
6 weeks.
Jump Performance
Time Frame: 6 weeks.
Countermovement Jump Test and Abalakov´s Test (jump height in cm).
6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luis Santos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 15, 2016

Study Registration Dates

First Submitted

March 18, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 53/2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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