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

NCT03848442 | Completed

• 1 other identifier: Center for RTT- 2017
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Rett Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

• 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

• Goal attainment scaling

  Assessed twice; at baseline and after the 12 week intervention

Study Arms (1)

UPART intervention group

EXPERIMENTAL

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

Interventions

'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)

UPART intervention group

Eligibility Criteria

• Age: 5 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation
• Hoffer ambulation scale levels I-IV

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Rett Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research physiotherapist

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 20, 2019
• Study Start: February 7, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)