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

NCT ID: NCT03848442

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2017-12-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

'Uptime' participation

Intervention Type: 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)

Interventions

'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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 5 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Michelle Stahlhut

Research physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine

Copenhagen, København Ø, Denmark

Countries

Denmark

Other Identifiers

Center for RTT- 2017

Identifier Type: -

Identifier Source: org_study_id