Effects of Muscle Strength Training in Lower Limb Amputee Patients
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Gran Rosario
- Enrollment
- 18
- Primary Endpoint
- Changes in Funcionality
Overview
Brief Summary
This study is a clinical trial that evaluates the best treatment option using a strength training protocol and an endurance training protocol in patients with lower limb amputations who use prostheses. The protocol consists of 6 weeks of strength training and 6 weeks of endurance training, with a 1-month washout period between the two.
Detailed Description
The assessments in this study focus primarily on strength, using a dynamometer and the 5 RM, functionality, using the AMP scale, mobility, using the TugTest, quality of life, using the WHOQOL-BREF, and perception of change, using the GROC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with unilateral lower limb amputation
- •Transtibial and/or transfemoral amputation
- •Prosthetized
- •Aged 18 to 75 years
- •Who sign the informed consent form
Exclusion Criteria
- •That they are unable to complete the initial assessment
- •That they undergo further secondary training
Outcomes
Primary Outcomes
Changes in Funcionality
Time Frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
It is assessed using the TUG test, which requires patients to get up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down again. Patients will receive the following instructions: "Get up on the word 'go,' walk to the tape, turn around, walk back to the chair, and sit down."
Changes in quality of life
Time Frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
It is assessed using a self-administered questionnaire called WHOQOL-BREF, which provides a profile of the person's perceived quality of life.
Secondary Outcomes
- Changes in Maximum isometric muscle strength(day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.)
- Changes on Movility(day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.)
- Change in Global percepcion of change(assessments were performed at the end each protocol. day 18 and day 24)
Investigators
Gabriela Dell Elce
principal investigator
University of Gran Rosario