'Uptime' Participation Intervention in Girls and Women With Rett Syndrome
- Conditions
- Rett Syndrome
- Interventions
- Other: 'Uptime' participation
- Registration Number
- NCT03848442
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 14
- Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation
- Hoffer ambulation scale levels I-IV
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description UPART intervention group 'Uptime' participation 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).
- Primary Outcome Measures
Name Time Method Stepwatch Activity Monitor 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 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 Outcome Measures
Name Time Method 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 Change in gross motor skills
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 Change in walking capacity
Goal attainment scaling Assessed twice; at baseline and after the 12 week intervention Change in participation level goals. Goal attainment scaling is a validated method for evaluating achievement of individual goals. Individual goals were assessed on a five-point rating scale ranging from -2 to +2. Baseline was set at -2, the expected level after the intervention at zero and the most favorable outcome at +2. The goals were graded in relation to frequency or duration of an activity.
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 Change in quality of life. The Quality of Life Inventory-Disability was used to assess quality of life. This 32 item-questionnaire was developed for children 5-18 years of age with ID. Responses are used to calculate an overall score and six subscale scores (social interaction, positive emotions, physical health, negative emotions, leisure/outdoors and independence), each scored on a 0-100 scale with higher scores representing better quality of life.
Trial Locations
- Locations (1)
Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine
🇩🇰Copenhagen, København Ø, Denmark