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GR IN: Evaluation of Group versus Individual Models of Physiotherapy for Children and Adolescents with Cerebral Palsy following Lower Limb Botulinum Toxin A injections.

A Single Blind Randomised Controlled Trial Comparing Group Versus Individual Models of Physiotherapy on Functional Mobility for Children and Adolescents with Cerebral Palsy following Lower Limb Botulinum Toxin A injections.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000454976
Acronym
GR IN
Enrollment
30
Registered
2011-05-03
Start date
2009-04-06
Completion date
2010-10-04
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This single blinded randomised controlled trial aims to investigate the relative effectiveness of two models of physiotherapy rehabilitation post lower limb Botulinum Toxin A (BoNTA) injections. Traditional individual rehabilitation will be compared to a group-based model for children aged 4-14 years with Cerebral Palsy (CP) attending the Queensland Cerebral Palsy Health Service (QCPHS) for BoNTA injections.

Interventions

For a given recruitment period, eligible subjects will be assessed at baseline 0-2 weeks prior to receiving lower limb Botulinum Toxin A (BoNTA) injections. All subjects will then receive lower limb BoNTA as per present QCPHS protocol. Muscles to be injected will be selected by the Clinic Rehabilitation Consultant and physiotherapist according to assessment findings and clinical indications. Muscles selected will accordingly vary between subjects but must be in the lower limb as stated in the i

For a given recruitment period, eligible subjects will be assessed at baseline 0-2 weeks prior to receiving lower limb Botulinum Toxin A (BoNTA) injections. All subjects will then receive lower limb BoNTA as per present QCPHS protocol. Muscles to be injected will be selected by the Clinic Rehabilitation Consultant and physiotherapist according to assessment findings and clinical indications. Muscles selected will accordingly vary between subjects but must be in the lower limb as stated in the inclusion criteria. In the ambulant population, common muscles injected include medial hamstrings, gastrocnemius, soleus and tibialis posterior. Dose is different for all children but is according to recommendations based on the consensus opinion of the 'We Move' Spasticity Study Group (2002). This is worked out on a dose/kilo/muscle ratio which calculates a total dose/kilo. The maximum dose allowed is 16 units/kilo or to a total adult dose of 400 units. 2-3 weeks post BoNTA injections, all subjects will commence their rehabilitation. Subjects will not be re-injected with BoNTA until completion of the rehabilitation and 6 month post BoNTA assessments (final assessment point and exit from study). The Children allocated to the group-based intervention will receive physiotherapy together in a small group (3 or more children) with a physiotherapist and assistant. The format will consist of: 5 minutes warm up (group activity); 10 minutes of lower limb stretching (as a group); 4x5 minute circuit stations (group, paired or individual) addressing 1. Functional Strengthening 2. Balance 3. Targeted Motor Control 4. Fitness/Agility; 5 minutes warm down (group activity). Dose will consist of 6 sessions of physiotherapy provided in 1 hour sessions over 6 weeks. A standardised, individualised (3 activities related to individual goals to be completed 3 times a week) Home Exercise Programme will also be given to each participant and progressed each week as appropriate.

Sponsors

Royal Children's Hospital and Health Service District
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

The study will include children/adolescents aged 4-14 years with a diagnosis of spastic cerebral palsy who: - are clients of the Queensland Cerebral Palsy Health Service - require lower limb BoNTA to improve gait or mobility - have a Gross Motor Function Classification System level I-III (Palisano, Rosenbaum et al. 1997) - can commit to an intensive block of post BoNTA physiotherapy rehabilitation. This consists of 60 minutes, 1x a week for a total period of 6 weeks. Content of each 60 minute rehabilitation session will include: 5 minutes warm up activity; 10 minutes of lower limb stretching; 4x5 minute circuit stations with 1 minute inbetween each station to allow for rest/set up/drink. Stations to address: 1. functional strengthening 2. balance 3. targeted motor control 4. fitness/agility; 5 minutes warm down activity; 10 minutes review of home programme

Exclusion criteria

Exclusion Criteria: - Unable to complete baseline assessments or their families are unable to commit to rehabilitation - Have had orthopaedic or neurological surgery and/or other new spasticity management (eg Baclofen) in the previous 6 months to commencing the study - Are unable to follow basic commands - Have co-morbidities which prevent them from exercising safely (eg cardiac, respiratory)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026