AmputationNCT07067203
The Relationship of Quadriceps and Hamstring Strength on Timed up and go Scores in Transtibial Amputees
A study testing Lafayette hand held dynamometer and Timed up and Go test in people with Amputation and Transtibial Amputation - Unilateral, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Amputation, Transtibial Amputation - Unilateral, Quadriceps Muscle Strength
- What is being tested?
- Lafayette hand held dynamometer and Timed up and Go test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 27 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between The Effect Of Quadriceps And Hamstring Strength On Timed Up And Go Scores In Adults With Tarns - Tibial Amputation
To investigate the correlation between the effect of quadriceps and hamstring strength on timed up and go scores in adults with tarns - tibial amputation
Read the detailed description
Lower limb amputation (LLA) has a significant socioeconomic and psychological impact on both individuals and communities. Despite these effects, major lower limb amputations remain relatively common worldwide. The causes of amputation vary by region, with the majority being non-traumatic in nature-most commonly linked to conditions such as diabetes mellitus, peripheral vascular disease, and cancer.
Individuals with lower limb amputation often experience musculoskeletal limitations, including reduced strength in the residual limb, limited range of motion (particularly in prosthetic joints), and challenges with postural control. As a result, they face a higher risk of falls compared to their able-bodied peers.
There has been limited research over the past two decades examining the use of the Timed Up and Go (TUG) test in adults with LLA. Since muscle strength plays a critical role in functional mobility, assessing the biomechanical and muscular conditions of individuals with amputation is essential for restoring daily function.
Unilateral amputation causes biomechanical asymmetries, making it important to monitor strength development in both the residual and intact limbs during prosthetic rehabilitation. Strength assessments can support balance recovery, improve movement confidence, and enhance gait performance.
Study Aim This study aims to explore the relationship between quadriceps strength in the amputated limb and Timed Up and Go (TUG) scores in adults with unilateral lower limb amputation. It will also investigate the association between hamstring strength and TUG scores in the same population.
- Conditions
- Amputation, Transtibial Amputation - Unilateral, Quadriceps Muscle Strength, Hamstring Muscle Strength, Timed Up and Go
- Being tested
- Lafayette hand held dynamometer, Timed up and Go test
- Keywords
- Transtibial amputation, transtibial amputee, Timed up and go, Hamstring muscle strength, quadriceps muscle strength, Transtibial amputation - unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lafayette hand held dynamometerDevice
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.
Timed up and Go testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Lafayette hand held dynamometer; Diagnostic Test: Timed up and Go test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Sep 2023
- Primary completion25 Apr 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Essam Mohamed Abdelhafez, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067203
- Sponsor's protocol ID
- P.T.REC/012/004809
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between The Effect Of Quadriceps And Hamstring Strength On Timed Up And Go Scores In Adults With Tarns - Tibial Amputation
- ClinicalTrials.gov ID
- NCT07067203
- Acronym / sponsor ID
- P.T.REC/012/004809
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the correlation between the effect of quadriceps and hamstring strength on timed up and go scores in adults with tarns - tibial amputation
Detailed description
Lower limb amputation (LLA) has a significant socioeconomic and psychological impact on both individuals and communities. Despite these effects, major lower limb amputations remain relatively common worldwide. The causes of amputation vary by region, with the majority being non-traumatic in nature-most commonly linked to conditions such as diabetes mellitus, peripheral vascular disease, and cancer.
Individuals with lower limb amputation often experience musculoskeletal limitations, including reduced strength in the residual limb, limited range of motion (particularly in prosthetic joints), and challenges with postural control. As a result, they face a higher risk of falls compared to their able-bodied peers.
There has been limited research over the past two decades examining the use of the Timed Up and Go (TUG) test in adults with LLA. Since muscle strength plays a critical role in functional mobility, assessing the biomechanical and muscular conditions of individuals with amputation is essential for restoring daily function.
Unilateral amputation causes biomechanical asymmetries, making it important to monitor strength development in both the residual and intact limbs during prosthetic rehabilitation. Strength assessments can support balance recovery, improve movement confidence, and enhance gait performance.
Study Aim This study aims to explore the relationship between quadriceps strength in the amputated limb and Timed Up and Go (TUG) scores in adults with unilateral lower limb amputation. It will also investigate the association between hamstring strength and TUG scores in the same population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Unilateral Transtibial Amputation | Experimental | Device: Lafayette hand held dynamometer, Diagnostic Test: Timed up and Go testParticipants 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lafayette hand held dynamometerMuscle 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. | Device | Adults with Unilateral Transtibial Amputation |
| Timed up and Go testTimed 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. | Diagnostic test | Adults with Unilateral Transtibial Amputation |
Primary outcome
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
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lafayette hand held dynamometer and Timed up and Go test in people with Amputation and Transtibial Amputation - Unilateral, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.