Feasibility and Effectiveness of an Individualized 12-week 'Uptime' Participation Intervention (U-PART) in Girls and Women With Rett Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Stepwatch Activity Monitor
Study Overview
Brief Summary
The aim of the study is to evaluate the feasibility and health-related effects of an individualized 12wk 'uptime' participation intervention in girls and women with Rett syndrome. Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation will be included. Each individual program focuses on participation in enjoyable activities to promote 'uptime' in home, school/day center and community settings. Primary outcomes are sedentary time and daily steps. Secondary outcomes are gross motor skills, walking capacity, quality of life and participation-level goals. Outcomes are evaluated on four occasions: at baseline and after a 6-week interval, immediately following the 12-week intervention program and 12 weeks after the intervention program.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation
- •Hoffer ambulation scale levels I-IV
Exclusion Criteria
- •Girls and women who have undergone orthopedic surgery in the lower extremities within the last 6 months
- •Girls and women who have undergone spinal fusion within the last 12 months
Arms & Interventions
UPART intervention group
A 1-group pretest-posttest design was conducted. Outcomes were evaluated on four occasions; twice during baseline separated by six weeks and immediately following a 12-week 'uptime' participation intervention and after a further 12 weeks (follow-up).
Intervention: 'Uptime' participation (Other)
Outcomes
Primary Outcomes
Stepwatch Activity Monitor
Time Frame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Change in daily step count
ActivPAL
Time Frame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Change in sedentary time
Secondary Outcomes
- Rett Syndrome Gross Motor Scale(Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up)
- 2 minute walk test(Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up)
- Goal attainment scaling(Assessed twice; at baseline and after the 12 week intervention)
- Quality of Life Inventory - Disability, questionnaire(Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up)
Investigators
Michelle Stahlhut
Research physiotherapist
Rigshospitalet, Denmark