'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
|Condition or disease||Intervention/treatment||Phase|
|Rett Syndrome||Other: 'Uptime' participation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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
- 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
- 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 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
- 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.
- 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.
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
|Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine|
|Copenhagen, København Ø, Denmark, 2100|