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Mobility Impairment in the Northern Region of Malawi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074252
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Project Malawi
Information provided by (Responsible Party):
Rachel Thompson, MD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Device: Lofstrand Crutches Device: Axillary Crutches Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT04074252


Contacts
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Contact: Jared M Alswang (303) 931-7223 jalswang2@gmail.com
Contact: Sierra M Pinal 6264828427 Sierra.pinal@gmail.com

Sponsors and Collaborators
University of California, Los Angeles
Project Malawi
Investigators
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Principal Investigator: Rachel M Thompson, MD UCLA/OIC
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Responsible Party: Rachel Thompson, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04074252    
Other Study ID Numbers: 19-000773
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms