Mobility Impairment in the Northern Region of Malawi

Mobility Limitation Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to investigate whether Lofstrand or axillary crutches are better suited to treat mobility impairments and improve physical activity levels in rural, resource-limited, settings like the Northern Region of Malawi. To do this, we are proposing the implementation of a randomized controlled trial (RCT) to measure and compare the physical activity and satisfaction of mobility aid recipients sorted into two groups - one receiving a set of Lofstrand crutches (Group 1) and the other a set of axillary crutches (Group 2). Changes in physical activity, disability, and life satisfaction levels will measured with a follow-up data collection period conducted one year after the distribution of the devices.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Mobility Limitation

• NCT number: NCT04074252
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2019
• Completion date: July 15, 2022