Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000166774
Ethics application status
Approved
Date submitted
11/02/2013
Date registered
11/02/2013
Date last updated
11/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial of the effect of balance training on walking confidence and balance in adults with cerebral palsy
Scientific title
In adults with cerebral palsy, what is the effect of a balance training program compared to a control intervention on walking confidence and balance?
Secondary ID [1] 281923 0
Nil
Universal Trial Number (UTN)
U1111-1139-4081
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 288320 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288674 288674 0 0
Physiotherapy
Neurological 288675 288675 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a physiotherapy program in small groups of 3 participants, once weekly for a 1.5 hour session for an 8 week intervention period. Participants will also perform a structured home practice session. The intervention will focus on individualized balance training, including practice of anticipatory and reactive dynamic balance strategies, dynamic gait training and strengthening exercises.
Intervention code [1] 286485 0
Rehabilitation
Comparator / control treatment
The control group will also attend in small groups of 3 participants, once weekly for a 1. 5 hour session for an 8 week intervention period, with equivalent therapist contact to the intervention group. Activities will incorporate activities such as guided relaxation, meditation, seated yoga and discussion groups structured to each group’s preferred topics of interest. No activities relating to walking or standing balance will be included.
Control group
Active

Outcomes
Primary outcome [1] 288823 0
Ambulation confidence (self efficacy); measured with the Ambulatory Self-Confidence Questionnaire
Timepoint [1] 288823 0
Baseline, after 8 week intervention and at 4 months
Primary outcome [2] 288824 0
Balance- as measured by the BESTest balance measure
Timepoint [2] 288824 0
Baseline, after 8 week intervention and at 4 months
Primary outcome [3] 288835 0
Safety and feasibility. Safety will be assessed during the intervention phase in three ways; (i) structured weekly
screening by the intervention therapists for any new muscle soreness lasting longer than 48 hours related to therapy; (ii) recording of adverse events that may occur during therapy; and (iii) fall rate during the intervention phase, as measured with falls calendars.
Retention and adherence will be assessed by the: (i) the proportion of participants who attend post-intervention assessments, and (ii) participant attendance at the intervention/control sessions. Reasons for not attending sessions will be recorded.
Timepoint [3] 288835 0
During the intervention period, after 8 week intervention and at 4 months.
Secondary outcome [1] 301092 0
Gait speed, endurance/functional walking capacity; measured with the Six minute Walk Test and GaitRite walkway
Timepoint [1] 301092 0
Baseline, after 8 week intervention and at 4 months
Secondary outcome [2] 301093 0
Fatigue; measured with The Fatigue Severity Scale
Timepoint [2] 301093 0
Baseline, after 8 week intervention and at 4 months
Secondary outcome [3] 301094 0
Perceived change, as measured with a Global Impression of Change scale
Timepoint [3] 301094 0
Baseline, after 8 week intervention and at 4 months
Secondary outcome [4] 301095 0
Physical Activity, as measures with The Physical Activity and Disability Survey — Revised (PADS-R)
Timepoint [4] 301095 0
Baseline, after 8 week intervention and at 4 months

Eligibility
Key inclusion criteria
To be included, participants will need to have a (i) diagnosis of Cerebral Palsy (CP), (ii) aged over 18 years (iii) Gross Motor Function Classification Scale (GMFCS) level I, II or III (i.e.; able to walk with mild difficulty or with an aid), (iv) able and willing to attend an 8 week therapy program, (v) medically permitted to participate in a balance and strengthening program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gross Motor Function Classification Sysytem (GMFCS) level IV or V, medical conditions that preclude safe participation in exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group they will be allocated. Allocation will be concealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 563 0
Southern Health

Funding & Sponsors
Funding source category [1] 286715 0
Charities/Societies/Foundations
Name [1] 286715 0
Lions John Cockayne Memorial Fellowship Trust Fund
Country [1] 286715 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
Southern Health
246 Clayton Road
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 285488 0
University
Name [1] 285488 0
University of Melbourne
Address [1] 285488 0
Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, 200 Berkeley St, Carlton, VIC 3010
Country [1] 285488 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288782 0
Southern Health HREC
Ethics committee address [1] 288782 0
Ethics committee country [1] 288782 0
Australia
Date submitted for ethics approval [1] 288782 0
Approval date [1] 288782 0
22/01/2013
Ethics approval number [1] 288782 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37726 0
Dr Jennifer McGinley
Address 37726 0
Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Alan Gilbert Building, 161 Barry Street, Carlton, VIC, 3053
Country 37726 0
Australia
Phone 37726 0
+61 3 834 44118
Fax 37726 0
Email 37726 0
[email protected]
Contact person for public queries
Name 37727 0
Dina Pogrebnoy
Address 37727 0
Clinical Gait Analysis Service
Kingston Centre
Cnr Warrigal and Heatherton Rd,
Cheltenham, VIC, 3192
Country 37727 0
Australia
Phone 37727 0
+61 3 9265 1360
Fax 37727 0
Email 37727 0
[email protected]
Contact person for scientific queries
Name 37728 0
Jennifer McGinley
Address 37728 0
Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Alan Gilbert Building, 161 Barry Street, Carlton, VIC, 3053
Country 37728 0
Australia
Phone 37728 0
+61 3 834 44118
Fax 37728 0
Email 37728 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.