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Clinical Trials/NCT03848442
NCT03848442
Completed
Not Applicable

Feasibility and Effectiveness of an Individualized 12-week 'Uptime' Participation Intervention (U-PART) in Girls and Women With Rett Syndrome

Rigshospitalet, Denmark1 site in 1 country14 target enrollmentFebruary 7, 2017
ConditionsRett Syndrome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rett Syndrome
Sponsor
Rigshospitalet, Denmark
Enrollment
14
Locations
1
Primary Endpoint
Stepwatch Activity Monitor
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 7, 2017
End Date
December 15, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle Stahlhut

Research physiotherapist

Rigshospitalet, Denmark

Eligibility Criteria

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

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)

Study Sites (1)

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