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Completed

NCT Number: NCT03848442

'Uptime' Participation Intervention 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.

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Key information

Conditions

Rett Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations X-Linked Intellectual Disability

Age range

5 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine

Copenhagen, København Ø, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

'Uptime' participation

Other

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2019
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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