Do Core Stability Exercise Classes Help Children With Cerebral Palsy Improve Their Balance

NCT02351596 | Unknown

• 1 other identifier: CPSP1415
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if participation in a core stability physiotherapy group programme can improve the balance of children with cerebral palsy. It is hypothesised that teaching the children how and when to activate their deep core stabilising muscles may help improve their body awareness and their ability to control their alignment and therefore positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who can walk independently, will be randomly selected to join either the control group or intervention group, after completion of their baseline balance assessments. Each group will be re-assessed after completion of their 4 week intervention or control period.

Conditions

Cerebral Palsy

Keywords

Core Stability; Balance; Core Control

Outcome Measures

Primary Outcomes (3)

• Changes in performance of a static balance task ( single leg stand) using three dimensional motion analysis

  o Relationship of Centre of Mass to Centre of Pressure

  Baseline and up to 3 weeks post intervention/control 4 week period

• Changes in performance of an anticipatory balance task using three dimensional motion analysis

  o Kinematic variables relating to trunk, pelvis, hip, knee and ankle movement at key points in the task of tandem walking.

  Baseline and up to 3 weeks post intervention/control 4 week period

• Changes in stride length when balance is challenged during gait using three dimensional gait analysis

  o Temporal-spatial parameters of stride length while walking over a 'wobbly road'. ( In gait lab setting this is achieved using bean bags placed under a mat.

  Baseline and up to 3 weeks post intervention/control 4 week period

Secondary Outcomes (2)

• Changes in a series of functional Balance tests: Berg Balance Scale and Functional Walk Test

  Baseline and up to 3 weeks post intervention/control 4 week period

• Qualitative data from a post intervention questionnaire to determine the broader effects of the 'Core stability' group intervention on the child's real life function, participation and quality of life.

  Up to 1 year Post intervention period

Study Arms (4)

Intervention Group 7-12 years

ACTIVE COMPARATOR

Intervention consists of attending a Physiotherapy Core stability group programme for 8 sessions over 4 weeks. Each session lasts 60 minutes (mins). Dosage: 60minsX 2 =120mins/week X 4 = 480 mins total dosage of intervention Participants also given a home exercise programme with a diary to record how long they practice for every day.

Other: Physiotherapy Core Stability Group Programme

Control Group 7-12 years

ACTIVE COMPARATOR

Participants continue with usual care but do not include core stability or balance specific exercises in their physiotherapy programme for the duration of the control period. If they are receiving active physiotherapy treatment during this time, the duration, type and frequency of this intervention is recorded.

Other: Control Group

Clontarf Intervention Group 13-17 years

ACTIVE COMPARATOR

Intervention consists of attending a Physiotherapy Core stability group programme for 8 sessions over 4 weeks. Each session lasts 60 minutes (mins). Dosage: 60minsX 2 =120mins/week X 4 = 480 mins total dosage of intervention Participants also given a home exercise programme with a diary to record how long they practice for every day.

Other: Physiotherapy Core Stability Group Programme

Clontarf Control Group 13-17 years

ACTIVE COMPARATOR

Participants continue with usual care but do not include core stability or balance specific exercises in their physiotherapy programme for the duration of the control period. If they are receiving active physiotherapy treatment during this time, the duration, type and frequency of this intervention is recorded.

Other: Control Group

Interventions

Physiotherapy Core Stability Group Programme OTHER

The aim of the intervention is to teach the participants active alignment and core stability, in order to influence their balance strategies. The exercises carried out will teach participants how and when to activate deep core stabilizing muscles. These exercises will be taught in a child-friendly way using imagery appropriate for the age of the participants. They will carry out activities like wall squats, 4-point kneeling, Transverses abdominis activation and gym ball sitting. Participants will also be supplied with a Home Exercise Programme (HEP) sheet with explanations for exercises that they will be asked to carry out on their 'off' days over the 4 week period. They will be asked to keep a record of their compliance with this.

Clontarf Intervention Group 13-17 years; Intervention Group 7-12 years

Control Group OTHER

The control group will partake in their usual physiotherapy care during the 4 week control period. They will not include core stability or balance specific exercises in their physiotherapy programme for the duration of the control period. If they are receiving active physiotherapy treatment during this time, the duration and frequency of this intervention is recorded

Clontarf Control Group 13-17 years; Control Group 7-12 years

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with spastic Cerebral Palsy (CP)
• Ages 7 - 17 (inclusive)
• GMFCS I-II (Gross Motor Function Classification System)
• Diplegia, Hemiplegia
• Balance problems identified (Determined by primary PT's treating problem list and/or score on balance assessments in use)
• Parental Informed Consent
• Can follow verbal instructions and willing to participate in a group intervention setting

You may not qualify if:

• Recent surgery to lower limbs (within past year)
• Botulinum Toxin (BTX-A) or serial casting to lower limbs within the last 3 months (or planned for during intervention or control period)
• Completed a core stability training group within the previous year
• Neurological or orthopaedic conditions unrelated to CP
• Behavioural difficulties limiting ability to participate in groups
• Intellectual difficulty that would make it difficult to comprehend and cooperate with treatment and/or testing

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Central Remedial Clinic: collaborator

Study Sites (1)

Central Remedial Clinic

Dublin, Dublin, D3, Ireland

RECRUITING

Related Publications (22)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dara Dr Meldrum, BSc,MSc,PhD

  Royal College of Surgeons, Ireland

  STUDY CHAIR

Central Study Contacts

Clodagh Ms Coman, BSc

CONTACT

01 85452200; clodaghcoman@rcsi.ie

Ailish Dr Malone, BSc,MSc,PhD

CONTACT

00353 1 8542200; ammalone@crc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Dara Meldrum BSc, MSc, PhD (NUI, RCSI), MISCP

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: January 30, 2015
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

IE (1)