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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03848442
Other study ID # Center for RTT- 2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 7, 2017
Est. completion date December 15, 2017

Study information

Verified date February 2019
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 15, 2017
Est. primary completion date December 15, 2017
Accepts healthy volunteers No
Gender Female
Age group 5 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
'Uptime' participation
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)

Locations

Country Name City State
Denmark Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine Copenhagen København Ø

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary ActivPAL Change in sedentary time Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Primary Stepwatch Activity Monitor Change in daily step count Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Secondary Rett Syndrome Gross Motor Scale Change in gross motor skills Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Secondary 2 minute walk test Change in walking capacity Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Secondary Quality of Life Inventory - Disability, questionnaire 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. Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Secondary Goal attainment scaling 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. Assessed twice; at baseline and after the 12 week intervention
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