The Relationship of Quadriceps and Hamstring Strength on Timed up and go Scores in Transtibial Amputees

NCT07067203 | Completed

• 1 other identifier: P.T.REC/012/004809
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the correlation between the effect of quadriceps and hamstring strength on timed up and go scores in adults with tarns - tibial amputation

Conditions

Amputation; Transtibial Amputation - Unilateral; Quadriceps Muscle Strength; Hamstring Muscle Strength; Timed Up and Go

Keywords

Transtibial amputation; transtibial amputee; Timed up and go; Hamstring muscle strength; quadriceps muscle strength; Transtibial amputation - unilateral

Outcome Measures

Primary Outcomes (1)

• Correlation between the effect of quadriceps and hamstring strength by using Lafayette hand held dynamometer on the average of timed up and go scores in adults with tarns - tibial amputation

  6 months

Study Arms (1)

Adults with Unilateral Transtibial Amputation

EXPERIMENTAL

Participants in this arm are adults aged 50 years or older with a unilateral transtibial amputation resulting from peripheral vascular disease or diabetic complications. All participants will have a K-level classification of 3 or 4 and a BMI within the normal range (18.5-29.9). Each participant will undergo two primary assessments: 1. Muscle Strength Measurement 2. Timed Up and Go (TUG) Test

Device: Lafayette hand held dynamometer; Diagnostic Test: Timed up and Go test

Interventions

Lafayette hand held dynamometer DEVICE

Muscle Strength Measurement: The strength of the quadriceps (knee extensors) and hamstrings (knee flexors) of the amputated limb will be measured using a handheld digital dynamometer (Nicholas MMT, Lafayette Instruments). Measurements will be taken with the prosthesis in place. Quadriceps strength will be assessed in a supine position with the knee at 30° flexion, while hamstring strength will be assessed in a prone position with the knee at 20° flexion. Each participant will perform three maximal effort trials after a practice attempt. The highest value will be scaled to body mass for analysis.

Adults with Unilateral Transtibial Amputation

Timed up and Go test DIAGNOSTIC_TEST

Timed Up and Go (TUG) Test: Participants will complete a standardized 3-meter TUG assessment to evaluate functional mobility. The test will be broken down into five components: standing, walking, turning, returning, and sitting. After one practice run, two timed trials will be conducted, and the average of both will be used for analysis. All procedures will be conducted by trained physical therapists following a standardized protocol.

Adults with Unilateral Transtibial Amputation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants age 50 years or older, with the reason for amputation either peripheral vascular disease or diabetic complications (Nadollek \& Brauer, 2002).
• Unilateral transtibial amputation only (Wood, 2022).
• K-level (2 to 4) (Gailey et al., 2002).
• Normal Body mass index ranged from 18.5 to 30.0 (Nuttall, 2015).

You may not qualify if:

• Residual limb revision in the past six months (Wood, 2022).
• Open wounds or sores on the residual limb limiting the ability to don/doff prosthesis (Wood, 2022).
• Uncontrolled comorbidities such as cardiovascular disease, active cancer treatment, and uncontrolled Diabetes Mellitus (Wood, 2022).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy College Cairo University

Giza, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2023
• Primary Completion: April 25, 2025
• Study Completion: May 27, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

EG (1)