MedTrace Logo

Mobility Impairment in the Northern Region of Malawi

NCT04074252 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-07-12

No results posted yet for this study

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.

Conditions

  • Mobility Limitation

Interventions

DEVICE

Lofstrand Crutches

Device: Set of Lofstrand Crutches

DEVICE

Axillary Crutches

Device: Set of Axillary Crutches

Sponsors & Collaborators

Principal Investigators

  • Rachel M Thompson, MD · UCLA/OIC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-07-15
Completion
2022-07-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04074252 on ClinicalTrials.gov