'Uptime' Participation Intervention in Girls and Women With Rett Syndrome

Not Applicable

Completed

• Conditions: Rett Syndrome

• 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

Study Timeline

• Study Start: 2017-02-07
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Status Verified: 2019-02
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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