Mobility Impairment in the Northern Region of Malawi

NCT04074252 | Withdrawn FDA Device

• 1 other identifier: 19-000773
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in scores between baseline and follow-up from the Global Physical Activity Questionnaire (QPAQ)

  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.

  Baseline and 1 year

Secondary Outcomes (3)

• Change in scores between baseline and follow-up from the PROMIS Satisfaction with Participation in Social Roles (SPSR) survey

  Baseline and 1 year

• Change in scores between baseline and follow-up from the PROMIS General Life Satisfaction (GLS) survey

  Baseline and 1 year

• Satisfaction Survey

  1 year

Study Arms (2)

Lofstrand Crutches

ACTIVE COMPARATOR

This group is given a set of Lofstrand crutches.

Device: Lofstrand Crutches

Axillary Crutches

ACTIVE COMPARATOR

This group is given a set of axillary crutches.

Device: Axillary Crutches

Interventions

Lofstrand Crutches DEVICE

Device: Set of Lofstrand Crutches

Lofstrand Crutches

Axillary Crutches DEVICE

Device: Set of Axillary Crutches

Axillary Crutches

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Persons fluent in English, Tumbuka, and/or Chichewa.
• Persons diagnosed with a moderate to severe mobility impairment and/or lower extremity disabilities as determined by the WGES Questions on Disability.
• Persons untreated or undertreated for mobility impairment. We consider undertreated persons as those treating their mobility impairments with self-made devices (i.e. wooden crutches or walking sticks), or with devices considered lower than standard of care for their level of impairment (i.e. using a cane instead of crutches).
• Persons who are candidates for both axillary and Lofstrand crutch treatment - as determined by gait analysis conducted by local physiotherapists.
• Persons accessing one of the following 15 outreach distribution clinics located throughout the Mzimba, Rumphi, and Nkhata Bay Districts: Mzuzu Central Hospital, Ekwendeni Mission Hospital, Mtwalo Health Centre, Rumphi MAP Office, Bolero Health Centre, Hewe Health Centre, Livingstonia Mission Hospital, Mhuju Health Centre, Mzimba District Hospital, Jenda Health Centre, Nkhata Bay District Hospital, Mpamba Health Centre, Maula Health Centre, Chintheche Health Centre, and Kande Health Centre.

You may not qualify if:

• Persons diagnosed with degenerative conditions that may lead to further deterioration in mobility between data collection periods (i.e. ALS, Muscular Dystrophy, Corticobasal Degeneration etc.)
• Persons with developmental delays that will preclude them from participation in any of the surveys
• Persons with upper extremity disabilities that may preclude them from using crutches.
• Persons who are not permanent residents of the area or have any plans on moving out of the area.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Project Malawi: collaborator

Study Sites (1)

Orthopaedic Institute for Children

Los Angeles, California, 90007, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel M Thompson, MD

  UCLA/OIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: August 30, 2019
• Study Start: May 1, 2019
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Locations

US (1)