Physiotherapy intervention for children with ataxia Nervous System Diseases Ataxia
Conditions
Interventions
Current intervention as of 29/12/2021:
The recruitment of the population will be carried out by private and public therapeutic areas. A group of children with ataxia, aged 8 to 18 years, will particip
Sponsors
University of West Attica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 29/12/2021: 1. Ataxia as their primary motor disorder, as a result of congenital, acquired or genetic damage 2. Gross Motor Function Classification System (GMFCS) II-IV 3. Aged 8-18 years 4. Attendance of a physiotherapy program in an outpatient or community setting the last 6 months after a relevant medical admission 5. Willingness to participate in the study. _____ Previous inclusion criteria as of 03/08/2021: 1. Ataxia as their primary motor disorder, as a result of congenital, acquired or genetic damage 2. Gross Motor Function Classification System (GMFCS) II-IV 3. Age 8 - 18 years old 4. Attendance of a physiotherapy program after a relevant medical admission 5. Willingness to participate in the study _____ Previous inclusion criteria: 1. Aged 8 - 18 years 2. Gross Motor Function Classification System (GMFCS) II-III 3. Ataxia as their primary motor disorder, as a result of congenital, acquired or genetic damage 4. Attendance of a physiotherapy program after a relevant medical admission and 5. Willingness to participate in the study.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 29/12/2021: 1. Invasive neurological or orthopedic intervention, such as botox injection, alcohol block, muscle-tendon lengthening, or tendon transfer surgery within 6 months from the study 2. Coexisting degenerative disorders, such as arthrogryposis 3. Significant heart or respiratory disease 4. Lower motor neuron disorder diagnosis, such as spinal muscular atrophy 5. Co-morbid conditions (not related to ataxia diagnosis) such as peripheral vascular disease and diabetic polyneuropathy 6. Coexisting musculoskeletal or rheumatoid disorder that prevents independent walking 7. Deficient ocular alertness 8. Cognitive impairments which restrict them from understanding commands, evidenced by their medical diagnosis or any kind of psychiatric disorder 9. Reluctance of parents to collaborate with the researchers for scheduling the timeframe of evaluations and/or intervention period _____ Previous exclusion criteria as of 03/08/2021: 1. invasive neurological or orthopedic intervention, such as botox injection, alcohol block, muscle-tendon lengthening, or tendon transfer surgery within 6 months from the study 2. coexisting degenerative disorders, such as Spinal Muscular Atrophy 3. significant medical heart or respiratory disease 4. lower motor neurons, such as sciatic nerve paralysis 5. co-morbid conditions such as peripheral vascular disease and diabetic polyneuropathy 6. coexisting musculoskeletal and rheumatoid disorder that prevents independent walking 7. deficient and/or ocular alertness 8. cognitive impairments which restrict them from understanding commands, evidenced by their medical diagnosis or any kind of psychiatric disorder 9. reluctant parents _____ Previous exclusion criteria: 1. Have undertaken invasive neurological or orthopedic intervention, such as botox injection, alcohol block, muscle-tendon lengthening, or tendon transfer surgery within 6 months from the study 2. Have coexisting degenerative disorders, such as Spinal Muscular Atrophy 3. Have significant medical heart or respiratory disease 4. Have Lower Motor Neurons, such as sciatic nerve paralysis 5. Have co-morbid conditions such as peripheral vascular disease and diabetic polyneuropathy 6. Have coexisting any musculoskeletal and rheumatoid disorder that prevents independent walking 7. Have deficient alertness 8. Are unable to understand commands as evidenced by their medical diagnosis or any kind of psychiatric disorder 9. Parents’ are reluctant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 29/12/2021: For the primary outcome measure there will be a first baseline assessment prior to the 4-week intervention period (pre), a 4-week post-assessment conducted by the end of the 4-week intervention period (4-week post) and a final 2-month post-assessment, conducted 2 months after the end of the 4-week intervention period (follow-up). 1. The Gross Motor Function Measure (GMFM-88) dimension D/E, will be expressed as percentage score (%) for assessment of the motor performance and functional ability in standing, walking, running and jumping. GMFM is considered the primary outcome measure, as this has been examined widely in pediatric population and can be affected positively after a therapeutic intervention. The change from pre to 4-week post of GMDF -D will be used as the primary endpoint for calculating the effect size, as this measure is more likely to be mostly affected. _____ Previous primary outcome measure as of 03/08/2021: Measured at baseline, 1 month and 3 months. All measurments will be in regards to coordination of movements, upright posture, static and dynamic balance, gait, physical activity and gross functional ability and will include: 1. Gross Motor Function Measure Domain D and E (GMFM-88) for assessing functional skills 2. 10 meters walking test for assessing walking cadence 3. Pediatric Balance Scale _____ Previous primary outcome measure: Measured at baseline, 1 month and 3 months. All measurments will be in regards to coordination of movements, upright posture, static and dynamic balance, gait, physical activity and gross functional ability and will include: 1. SARA Scale of Assessing and Rating Ataxia for assessing ataxia 2. Gross Motor Function Measure Domain D and E (GMFM-88) for assessing functional skills 3. 10 meters walking test for assessing walking cadence 4. 6min Walk Test for assessing physical activity-endurance 5. Timed-Up and Go test for assessing walking speed and independent walkin | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/12/2021: Similarly, for secondary outcome measures there will be a first baseline assessment prior to the 4-week intervention period (pre), a 4-week post-assessment, conducted by the end of the 4-week intervention period (4-week post) and a final 2-months post-assessment, conducted 2 months after the end of the 4-week intervention period (follow-up) 1. Functional balance skills assessed using the Pediatric Balance Scale, with score ranging 0–56 (higher score indicates better balance) 2. Gait speed assessed using the 10-m walk test on the treadmill 3. Dynamic balance control assessed using the Timed Up and Go test 4. Physical condition and endurance assessed using the 6-min walk test 5. Ataxia severity assessed using the Scale for Assessment and Rating Ataxia (SARA), applied in the Greek version, with score range 0–40 (higher score indicates more severe ataxia) 6. Spatiotemporal gait parameters assessed using GaitSens software through LiteGait and specific treadmill usage 7. Three-dimensional kinematic and kinetic analysis of lower limbs through motion and gait analysis applied with electronic recording of kinematics elements for the pelvis, hip, knee and foot of both lower limbs in the three planes of motion (sagittal, frontal and transverse) _____ Previous secondary outcome measures as of 03/08/2021: 1. Anthropometric data: age, weight (kg), BMI (kg/m²), height (cm) and data regarding medical records will be assessed at baseline 2. Quality of life measured using the Child quality of Life Questionnaire for child report measured at baseline. All other measurements will be assessed at baseline, 1 month and 3 months. 3. SARA Scale of Assessing and Rating Ataxia for assessing ataxia 4. 6min Walk Test for assessing physical activity-endurance 5. Timed-Up and Go test for assessing walking speed and independent walking ability 6. Spatiotemporal gait parameters through GaitSens software through LiteGait and specific treadmill | — |
Countries
Greece
Contacts
Public ContactVasiliki;Sofia Sakellari;Lampropoulou
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Outcome results
None listed