Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000890538p
Ethics application status
Not yet submitted
Date submitted
4/07/2024
Date registered
22/07/2024
Date last updated
22/07/2024
Date data sharing statement initially provided
22/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Constraint Induced Movement Therapy for the lower extremity for children with unilateral cerebral palsy - a pilot study
Scientific title
Evaluating the effect of Constraint Induced Movement Therapy for the lower extremity on lower limb function in 4-8 year old children with unilateral cerebral palsy - a pilot pre-post feasibility study
Secondary ID [1] 312448 0
None
Universal Trial Number (UTN)
U1111-1310-2176
Trial acronym
CIMT-Leg 4-8
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 334279 0
Condition category
Condition code
Neurological 330937 330937 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 330938 330938 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Background: Contstraint Induced Movement Therapy for the Leg (CIMT-Leg) is a type of functional therapy (also known as task-specific training) for children with unilateral cerebral palsy targeting the function of the more-affected lower extremity (leg).

Dose: 67 hours, consisting of: (1) 30 minutes goal setting with the child and their caregiver, (2) 6 hours of 1:1 physiotherapy sessions at an intensity of 1 hour per week over 6 weeks, delivered either in-clinic, or as alternating in-clinic and telepractice appointments, (3) Up to 60 hours of structured home practice supervised by the child's caregiver (2 hours per day, 5 days per week over the same 6 week intervention period), (4) 30 minutes goal scoring (COPM) and update of the transfer package (to carry on with post-intervention).

Materials: During physiotherapy sessions and home practice time, the child wears a pre-fabricated restraint applied to their less-affected lower extremity (rigid knee immobilizer splint – Jobskin RTW Standard Leg/Arm Gaiter) - sized according to limb length as well as goal. Generally the restraint extends from the groin to the just above the ankle. The home exercise program, developed for each child specifically for this study, is articulated in a written transfer package provided to the child and their caregivers including instructions about how to perform each exercise, accompanied by images/diagrams. The home exercise program is updated weekly. A parent log will be used to record the amount of home practice completed.

Delivery mode: 1:1 therapist:child.

Interventionists: Registered physiotherapists who have completed a standardized training package in the delivery of CIMT-Leg consisting of 2 hours of lecture material and a written instruction manual. The written instruction manual was developed by Cerebral Palsy Alliance (CPA) in 2017 (updated 2020) for use in clinical practice and will be adapted for this clinical trial.

Location: In clinic-sessions will take place at a CPA therapy centre, located across NSW and ACT, Australia. Telepractice sessions will take place with the participant and their caregiver at home, using a either HealthDirect or Microsoft Teams as a telepractice platform. Goal-setting and goal-scoring sessions will take place either at a CPA therapy centre or using telepractice. Structured home practice will take place at the participant's home.

Tailoring: Content of therapy sessions will be tailored to the child's goals, abilities, interests and motivation. Common goal activities are likely to include: independent standing, supported forward walking, independent walking, improved static and dynamic postural control in standing, running, stair climbing, hopping/jumping, balancing on one leg, kicking balls etc. Specific exercises applied during the physiotherapy sessions and prescribed for home exercise programs will be designed to target the child's goals by addressing goal limiting factors, starting with part-task practice then incrementally increasing in difficulty towards whole task practice (which may involve removal of the restraint for brief periods).

Example exercises: If a child's goal is to "walk up stairs independently and reciprocally without a railing" and their goal limiting factors include: reduced weight shift to the more-affected side (with limited stance time and poor medio-lateral postural control), reduced active hip flexion range of motion, reduced strength of leg extensors, and limited task knowledge, a series of exercises may be as follows:
(A) Wearing the restraint
1. Weight shift to the more-affected side on flat ground by transferring toys using the hands and reaching from the less-affected to the more-affected side. 2. As above on unstable surface. 3. Tapping the top of an 8cm step with the more-affected side without holding onto a rail. 4. As above with 16cm step. 5. Stepping up onto an 8cm step with the more-affected side without holding onto a rail. 6. As above with 16cm step. 7. Taking 2 reciprocal steps holding onto a rail. 8. As above - gradually increasing the number of steps. 9. Taking 2 reciprocal steps without holding onto a rail. 10. As above - gradually increasing the number of steps.
(B) Without restraint
1. Tapping the top of an 8cm step with the less-affected side, while maintaining the more-affected side in as much extension as possible without holding onto a rail. 2. As above with 16cm step. 3. Stepping up onto an 8cm step with the less-affected side without holding onto a rail. 4. As above with 16cm step. 5. Taking 2 reciprocal steps holding onto a rail. 6. As above - gradually increasing the number of steps. 7. Taking 2 reciprocal steps without holding onto a rail. 8. As above - gradually increasing the number of steps.
(C) Adjuncts
1. Verbal and visual feedback appropriate to the child's stage of motor learning, including feedback designed to help the child problem solve the task and internalise the motor planning process.

Fidelity: Ongoing support to therapists to maintain fidelity will be provided remotely via teleconference in a group setting for 1 hour every two months through the study period and individual clinical supervision when required.

Adherence: Checklists will be used to monitor session attendance. Exercises completed during each therapy session will be recorded in session notes. The parent log will be used to record the amount of home practice completed.
Intervention code [1] 328954 0
Rehabilitation
Intervention code [2] 329048 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338712 0
Acceptability (parent-rated and caregiver-rated)
Timepoint [1] 338712 0
Immediately post-completion of 6-week intervention
Primary outcome [2] 338713 0
Demand
Timepoint [2] 338713 0
Upon conclusion of the study
Primary outcome [3] 338714 0
Implementation (dose)
Timepoint [3] 338714 0
Immediately post-completion of 6-week intervention
Secondary outcome [1] 437083 0
Adaptation
Timepoint [1] 437083 0
Immediately post-completion of 6-week intervention
Secondary outcome [2] 437084 0
Integration
Timepoint [2] 437084 0
Upon conclusion of the study
Secondary outcome [3] 437085 0
Change in performance of lower limb gross motor activity and/or participation goals (this will be assessed as a composite outcome)
Timepoint [3] 437085 0
Immediately post-completion of 6-week intervention
Secondary outcome [4] 437086 0
Change in satisfaction with performance of lower limb gross motor activity and/or participation goals (this will be assessed as a composite outcome)
Timepoint [4] 437086 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [5] 437087 0
Change in gross motor quality of movement
Timepoint [5] 437087 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [6] 437088 0
Change in gross motor capacity in standing domain
Timepoint [6] 437088 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [7] 437089 0
Change in parent-reported locomotion performance
Timepoint [7] 437089 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [8] 437090 0
Change in postural control
Timepoint [8] 437090 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [9] 437091 0
Change in parent-reported gait related function
Timepoint [9] 437091 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [10] 437092 0
Change in gait speed
Timepoint [10] 437092 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [11] 437093 0
Change in gait cadence
Timepoint [11] 437093 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [12] 437094 0
Change in step time
Timepoint [12] 437094 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [13] 437095 0
Change in stance phase as a percentage of the gait cycle
Timepoint [13] 437095 0
Baseline and Immediately post-completion of 6-week intervention
Secondary outcome [14] 437096 0
Safety
Timepoint [14] 437096 0
Collected weekly and collated upon study completion.
Secondary outcome [15] 437550 0
Change in gross motor capacity in walking domain
Timepoint [15] 437550 0
Baseline and Immediately post-completion of 6-week intervention

Eligibility
Key inclusion criteria
(1) Diagnosis from neurologist, paediatrician or rehabilitation physician of unilateral cerebral palsy with spastic and/or dyskinetic motor type/s.
(2) Gross Motor Function Classification System level I-III.
(3) 4-8 years old at the time of baseline assessment.
Minimum age
4 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Child unable to follow directions sufficiently to complete the outcome measures in the opinion of the investigator team.
(2) Orthopaedic and/or neurological surgery less than 6 months prior to baseline or planned within the study period.
(3) Botulinum Neurotoxin-A injection in the more-affected lower extremity less than 3 months prior to baseline or planned within the study period.
(4) Unstable medical conditions (e.g. uncontrolled epilepsy, uncontrolled asthma etc.) without clearance from a medical doctor (stable medical conditions are OK).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
(1) Summary of participant characteristics, summary of quantitative outcomes, and Acceptability, Demand, Implementation, Adaptation and Safety: n= (%), range, mean (SD) and/or median (IQR).
(2) Limited efficacy testing (COPM, Quality FM, GMFM-88, ABILOCO-Kids, Kids-BESTest, GOAL, GAITrite temporospatial gait parameters): paired sample t-tests or non-parametric equivalent.
(3) Integration: thematic content analysis of interview transcripts.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
20/10/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 316865 0
Charities/Societies/Foundations
Name [1] 316865 0
Cerebral Palsy Alliance
Country [1] 316865 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319112 0
None
Name [1] 319112 0
Address [1] 319112 0
Country [1] 319112 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315624 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315624 0
Ethics committee country [1] 315624 0
Australia
Date submitted for ethics approval [1] 315624 0
21/10/2024
Approval date [1] 315624 0
Ethics approval number [1] 315624 0

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

Contacts
Principal investigator
Name 135298 0
Dr Sarah Reedman
Address 135298 0
Cerebral Palsy Alliance, The University of Sydney, Brain and Mind Centre, Level 4, 88 Mallett Street, Camperdown, NSW 2050
Country 135298 0
Australia
Phone 135298 0
+61280522074
Fax 135298 0
Email 135298 0
[email protected]
Contact person for public queries
Name 135299 0
Sarah Reedman
Address 135299 0
Cerebral Palsy Alliance, The University of Sydney, Brain and Mind Centre, Level 4, 88 Mallett Street, Camperdown, NSW 2050
Country 135299 0
Australia
Phone 135299 0
+61280522074
Fax 135299 0
Email 135299 0
[email protected]
Contact person for scientific queries
Name 135300 0
Sarah Reedman
Address 135300 0
Cerebral Palsy Alliance, The University of Sydney, Brain and Mind Centre, Level 4, 88 Mallett Street, Camperdown, NSW 2050
Country 135300 0
Australia
Phone 135300 0
+61280522074
Fax 135300 0
Email 135300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data following de-identification
When will data be available (start and end dates)?
Start date: immediately following publication of the results
End date: no end date determined
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Contact: Dr Sarah Reedman, email: [email protected])


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.