Children with haemophilia Haematological Disorders Hereditary factor VIII deficiency
Conditions
Interventions
Randomisation of eligible participants will be performed with the online randomisation service http://sealedenvelope.com/. Utilising the secure, centralised and independent service, participants will
treatment group 2: usual physiotherapy care for 12 weeks) on a ratio of 1:1. Allocation will be stratified by centre to ensure the same numbers of participants at each site are allocated to the two gr
Sponsors
East Kent Hospitals University NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Diagnosis of severe or moderate haemophilia and registered with a UK Haemophilia Centre 2. Aged 6 – 12 years 3. Inhibitor or non-inhibitor 4. Able to follow simple verbal instructions and provide informed consent
Exclusion criteria
Exclusion criteria: 1. Children 13 years or older (boys aged 13 years or older are excluded due to confounding effects of non-linear increases in neuromuscular maturation and muscle strength that occur in boys during puberty and adolescence) 2. von Willebrand disease 3. Past history of fracture or trauma to the lower limb 4. Past history of orthopaedic surgery of the lower limb 5. Past history of acquired brain injury 6. Past history of any other disturbance of the central nervous system 7. Joint or muscle bleed in the lower limb in the past 6 weeks 8. Presence of lower limb pain 9. Participants who are unable to fully comply with verbal instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle strength of the dominant knee extensors measured using maximum voluntary isometric contraction at baseline, 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Muscle strength of the ankle plantarflexors and non-dominant knee extensors measured using maximum voluntary isometric contraction at baseline, 12 and 24 weeks 2. Physical function measured using the 6-minute timed walk, timed up and down stairs, triple hop and vertical jump tests at baseline, 12 and 24 weeks 3. Physical activity measured using daily step counts, sedentary time, time spent in moderate and vigorous-intensity physical activity using a wearable activity tracker at baseline, 12 and 24 weeks 4. Quality of life and QALY measured using the EuroQol-5D (EQ-5D) and Child Health Utility 9D (CHU9D) at baseline, 12 and 24 weeks 5. Safety and adherence assessed using adverse events, pain and exercise counts at 12 weeks 6. Intervention practicalities assessed using semi-structured interviews at the end of the intervention at 12 weeks | — |
Countries
United Kingdom
Outcome results
None listed