- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03848442
'Uptime' Participation Intervention in Girls and Women With Rett Syndrome
February 20, 2019 updated by: Michelle Stahlhut, Rigshospitalet, Denmark
Feasibility and Effectiveness of an Individualized 12-week 'Uptime' Participation Intervention (U-PART) in Girls and Women With Rett Syndrome
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 Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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København Ø
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Copenhagen, København Ø, Denmark, 2100
- Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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).
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The intervention are designed for each individual and are consistent with the model for participation-based interventions.
The interventions are goal-oriented (meaningful and family/client-selected goals), family/client-centered (promoted self-determination and decision making), collaborative (partnership between caregivers), strength-based (built on participant and caregiver strengths) and ecological (natural environment and real-life experiences).
Design of the intervention comprised three steps: 1) Preparation period (6 weeks); 2) Intervention period (12 weeks); 3) Follow-up period (12 weeks)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ActivPAL
Time Frame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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Change in sedentary time
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Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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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
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Change in daily step count
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Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rett Syndrome Gross Motor Scale
Time Frame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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Change in gross motor skills
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Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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2 minute walk test
Time Frame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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Change in walking capacity
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Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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Quality of Life Inventory - Disability, questionnaire
Time Frame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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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.
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Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
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Goal attainment scaling
Time Frame: Assessed twice; at baseline and after the 12 week intervention
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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.
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Assessed twice; at baseline and after the 12 week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 7, 2017
Primary Completion (ACTUAL)
December 15, 2017
Study Completion (ACTUAL)
December 15, 2017
Study Registration Dates
First Submitted
February 8, 2019
First Submitted That Met QC Criteria
February 19, 2019
First Posted (ACTUAL)
February 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Center for RTT- 2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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