Mobility Impairment in the Northern Region of Malawi
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|ClinicalTrials.gov Identifier: NCT04074252|
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mobility Limitation||Device: Lofstrand Crutches Device: Axillary Crutches||Not Applicable|
STAGE 1 - BASELINE DATA COLLECTION:
- Potential participants will be identified at outreach clinics in the Mzimba, Rumphi, and Nkhata Bay Districts for participation in the study.
- Potential participants will take the Washington Group Extended Set Questions on Disability (WGES) and those that meet a baseline level of disability/mobility impairment - validated by physiotherapist opinion - are invited to participate in the study.
- 100 or more participants (50+ per group) who fulfill the inclusion criteria will be selected for participation.
- Participants will complete a Demographic Survey to determine their age, gender, health barriers, social determinants of health etc.
- Participants will complete the Global Physical Activity Questionnaire (GPAQ) to determine a baseline of their physical activity.
- Participants will complete the PROMIS Satisfaction with Participation in Social Roles - Short Form 8a (SPSR) and General Life Satisfaction (Ages 18+) - Fixed Form A (GLS) questionnaires to determine a baseline of their overall life satisfaction.
- Treatment groups will be randomized through the use of randomization envelopes.
- Selected devices, as determined in the randomization process, will be distributed to participants in each treatment group.
- The addresses/villages of residences of selected participants will be recorded and marked manually on a detailed satellite map. A list of study participants will be provided to the local Health Surveillance Assistant (HSA) for record keeping and monitoring purposes. (HSAs have intimate knowledge of the communities they serve and will be useful partners to help find participants in the follow-up stages of the trial.)
STAGE 2 - ONE-YEAR FOLLOW-UP DATA COLLECTION:
- Participants will be located using the assistance of the local HSA, address records, and map markings from Stage 1.
- Participants will complete follow-up SPSR, GLS, WGES and GPAQ questionnaires, and will complete the Crutch Satisfaction Survey.
- Reports of missing and damaged crutches will be taken.
STAGE 3 - DATA ANALYSIS:
The two study groups will be compared using the following metrics:
- Stratified by level of disability based on Washington Group Extended Set Questions on Disability
- Changes in GLS and SPSR scores between baseline and follow-up data collection will be used to determine changes in participants' overall life satisfaction.
- Changes in Global Physical Activity Questionnaire scores between baseline and follow-up data collection will be used to determine changes in participants' mobility impairments and day-to-day activity levels.
- Scores from the Crutch Satisfaction Survey will be used determine participants' subjective experiences with their respective mobility devices.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coupling the Surveillance of Mobility Impaired Adults With Large-Scale Assistive Device Donations and the Suitability of the Long-Term Use of Lofstrand (Forearm) Versus Axillary (Underarm) Crutches Among Mobility Impaired Adults in the Northern Region of Malawi|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||July 15, 2020|
|Estimated Study Completion Date :||July 15, 2020|
Active Comparator: Lofstrand Crutches
This group is given a set of Lofstrand crutches.
Device: Lofstrand Crutches
Device: Set of Lofstrand Crutches
Active Comparator: Axillary Crutches
This group is given a set of axillary crutches.
Device: Axillary Crutches
Device: Set of Axillary Crutches
- Change in scores between baseline and follow-up from the Global Physical Activity Questionnaire (QPAQ) [ Time Frame: Baseline and 1 year ]Questionnaire used to measure the patient's self reported level of physical activity. There are 16 questions total. The majority of the questions are binary, but there are a few questions that include a measurement of time (in minutes, hours, and days). There is a numerical output.
- Change in scores between baseline and follow-up from the PROMIS Satisfaction with Participation in Social Roles (SPSR) survey [ Time Frame: Baseline and 1 year ]Questionnaire used to measure the patient's self reported level of satisfaction with current social roles. There are 7 ordinal type questions, each with 5 different rating options to choose from. There is a numerical output.
- Change in scores between baseline and follow-up from the PROMIS General Life Satisfaction (GLS) survey [ Time Frame: Baseline and 1 year ]Questionnaire used to measure the patient's self reported level of satisfaction with general life satisfaction. There are 7 ordinal type questions, each with 5 different rating options to choose from. There is a numerical output.
- Satisfaction Survey [ Time Frame: 1 year ]Questionnaire used to measure the patient's self reported satisfaction with their assigned devices. There is a numerical output.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074252
|Contact: Jared M Alswang||(303) email@example.com|
|Contact: Sierra M Pinal||6264828427||Sierra.firstname.lastname@example.org|
|Principal Investigator:||Rachel M Thompson, MD||UCLA/OIC|