NCT03486483

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
Last Updated

April 4, 2018

Status Verified

March 1, 2018

Enrollment Period

Same day

First QC Date

March 18, 2018

Last Update Submit

April 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 weeks.

Secondary Outcomes (2)

  • Myoelectrical activity.

    6 weeks.

  • Jump Performance

    6 weeks.

Study Arms (2)

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.

Other: Exercise

Physical Activity

NO INTERVENTION

The control group followed its usual weekly physical activity routine.

Interventions

Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.

Supervised Slackline Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

March 18, 2018

First Posted

April 3, 2018

Study Start

April 1, 2015

Primary Completion

April 1, 2015

Study Completion

May 15, 2016

Last Updated

April 4, 2018

Record last verified: 2018-03