Physical Activity in Adults With Amputation

NCT03722797 | Terminated

• 1 other identifier: 1046346
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study explores physical activity and energy expenditure among inactive adults with a unilateral transtibial amputation. Results may assist with physical activity prescription for adults with unilateral lower-limb loss.

Conditions

Amputees

Keywords

energy metabolism; walking; exercise

Outcome Measures

Primary Outcomes (1)

• Change in gait speed pre- and post-walking tests

  self-selected and fast speeds obtained with GaitRite

  immediately before/after

Secondary Outcomes (1)

• Change in gait symmetry

  immediately before/after

Study Arms (2)

Unilateral Transtibial Amputation

Individuals with a unilateral, transtibial amputation.

Procedure: Metabolic Cost Testing Procedures

Controls

Healthy adults without a lower-limb amputation who have been matched to participants in the Unilateral Transtibial Amputation group based on age, sex, and body mass index.

Procedure: Metabolic Cost Testing Procedures

Interventions

Metabolic Cost Testing Procedures PROCEDURE

The Oxycon Mobile™Portable VO2 Measurement system will be used to measure VO2 uptake during 2 walking tests. Test order will be randomized. Treadmill Test: Participants will walk on a treadmill at constant speed, based on the participant's self-selected gait speed, for 2.5 minutes in each stage. Walking will occur at 75% of self-selected gait speed in stage 1, 100% in stage 2, and 125% in stage 3. Over-ground Test: Participants will walk in an uncarpeted corridor on a course consisting of 2 cones, 20-meters apart. Participants will be instructed to walk at a constant speed for 2.5 minutes in each stage. Instructions will be to walk at their "slow" speed in stage 1, their "usual, comfortable" speed in stage 2, and their "brisk" speed in stage 3.

Controls; Unilateral Transtibial Amputation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will recruit 22 (males and females) with a unilateral (i.e. single limb), transtibial (i.e. below-the-knee) amputation. Given the prevalence of amputations is greater in males, it is expected that the sample will be predominantly male, but there will not be any inclusion/exclusion criteria related to sex. 20 controls will be recruited as age-, sex-, and body mass index-matched controls for those with a unilateral transtibial amputation who complete the entire study evaluation protocol.

You may qualify if:

• Ages 18-60 years
• Able to read and speak English
• Saltin-Grimby Physical Activity Level of I or II
• Unilateral, transtibial (below-the-knee) amputation
• Currently wearing a prosthesis with use of an assistive device no greater than a cane
• Wearing prosthetic at least 8 hours per day and inside and outside the home: This criteria will help to ensure that adults are beyond the initial weaning into a prosthetic period and are prosthetic users rather than nonusers.
• Pain-free in the legs and low back regions
• Able to walk without an assistive device

You may not qualify if:

• Current infections or illnesses that would affect safe participation in the study
• Past medical history of significant cardiovascular disease (e.g. congestive heart failure or previous heart attacks), significant neurological disease (e.g. Parkinson's, Multiple Sclerosis) significant neurological event (e.g. stroke), or major lung condition (e.g. Chronic obstructive pulmonary disease, emphysema)
• Uncontrolled high blood pressure
• Uncontrolled Diabetes Mellitus

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware STAR Campus

Newark, Delaware, 19713, United States

Location

Related Publications (57)

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jaclyn M Sions, PhD, PT, DPT

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Physical Therapy

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: October 29, 2018
• Study Start: May 11, 2017
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)