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

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ClinicalTrials.gov Identifier: NCT03848442
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle Stahlhut, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rett Syndrome Other: 'Uptime' participation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Effectiveness of an Individualized 12-week 'Uptime' Participation Intervention (U-PART) in Girls and Women With Rett Syndrome
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rett Syndrome

Arms and Interventions
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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).
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    Change in gross motor skills

  2. 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 ]
    Change in walking capacity

  3. 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 ]
    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.

  4. Goal attainment scaling [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848442


Locations
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Denmark
Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine
Copenhagen, København Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information
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Responsible Party: Michelle Stahlhut, Research physiotherapist, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03848442    
Other Study ID Numbers: Center for RTT- 2017
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rett Syndrome
Syndrome
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System