Flexor Hallucis Longus Muscle Strength in Elderly IndividualsNCT06887478
Flexor Hallucis Longus Training and Balance-Gait in Geriatrics
A study testing Exercise in people with Flexor Hallucis Longus Muscle Strength in Elderly Individuals, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
Examination of Balance-Gait Parameters and Fall Effect of Flexor Hallucis Longus Muscle Strengthening Training in Geriatric Group It has been demonstrated that the reduction in the strength of the toe flexor muscles is an independent indicator of falls in geriatric individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Flexor Hallucis Longus Muscle Strength in Elderly Individuals
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 31 Mar 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals over the age of 65,
- Individuals who do not have hearing or speech problems,
- Individuals who do not have any neurological, orthopedic or visual problems that would prevent walking (can walk 10 meters independently)
- Individuals who score 24 points and above in the Mini Mental Test evaluation.
Who cannot join
- Those who cannot walk independently,
- Those with serious musculoskeletal system disorders,
- Those with hallux rigidus deformity,
- Those with orthostatic hypotension,
- Those who have difficulty understanding instructions and those with diabetic neuropathy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atakum Nursing Home, Elderly Care and Rehabilitation Center
Samsun, Samsun, 55200
About this study
Official title: Examination of Balance-Gait Parameters and Fall Effect of Flexor Hallucis Longus Muscle Strengthening Training in Geriatric Group
Examination of Balance-Gait Parameters and Fall Effect of Flexor Hallucis Longus Muscle Strengthening Training in Geriatric Group It has been demonstrated that the reduction in the strength of the toe flexor muscles is an independent indicator of falls in geriatric individuals. However, the extent of this strength loss and the effects of strengthening training programs on balance, gait parameters, and falls are not well understood.
Objective: The aim is to investigate whether a progressive resistance exercise program, focusing specifically on the flexor hallucis longus (FHL) muscle, can improve toe flexor strength and influence gait, balance, and falls in geriatric individuals.
Read more
Materials and Methods: Individuals over the age of 65 who are willing to participate in the study will be included. The participants will be divided into three groups: individual exercise group, home exercise group, and control group. Individuals who are unable to walk independently, have severe musculoskeletal disorders, have hallux rigidus deformity, suffer from orthostatic hypotension, have difficulty understanding instructions, or have diabetic neuropathy will be excluded from the study. After obtaining socio-demographic information from the participants, anthropometric measurements will be taken. Toe grip strength will be assessed using a digital dynamometer, and the strength of the intrinsic foot muscles and lower extremity antigravity muscles will also be measured using a digital dynamometer. Balance parameters will be evaluated using the Berg Balance Scale, Functional Reach Test, Timed Up and Go Test, while gait parameters will be assessed using the 10-meter walk test and Tinetti Gait Scale. Fall parameters will be assessed by the Falls Efficacy Scale and fall frequency.
The collected data will be analyzed using SPSS (Statistical Package for Social Sciences) software.
- Being tested
- Exercise
- Keywords
- elderly, flexor hallucis longus, balance, gait, falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A progressive resistance exercise program focusing on strengthening the flexor hallucis longus (FHL) muscle in elderly participants.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist-Assisted Isolated FHL Strengthening Exercise Group | Experimental | The intervention for the "Physiotherapist-Assisted Isolated FHL Strengthening Exercise Group (FHL-SET)" will consist of physiotherapist-guided, isolated strengthening exercises specifically targeting the Flexor Hallucis Longus (FHL) muscle. Participants will engage in exercises designed to isolate and strengthen the FHL muscle through controlled and progressive resistance. Sessions will occur three times a week for 8 weeks, with the physiotherapist providing individualized adjustments and ensuring proper technique and progression. Receives: Other: Exercise |
| Home-Based Foot and Ankle Strengthening Exercise Training Group | Experimental | After the initial assessments, the participants in this group will receive home-based foot and ankle strengthening exercises three times a week for 8 weeks. They will be monitored weekly using an exercise log. The Home-Based Exercise Group (EvT-KE) will be taught general foot exercises without progression in resistance. These exercises include ankle rotations, toe raises, toe lifts, rolling a ball under the foot for 2 minutes, picking up marbles with toes, towel collection exercises, and foot shortening exercises. Receives: Other: Exercise |
| Control Group | No intervention | For the Control Group, initial and final assessments will be conducted at the beginning of the study and at the end of 8 weeks. No exercise program will be provided during this period. After the study, necessary exercises and recommendations will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength Measurement
Flexor hallucis longus strength and toe grip strength will be assessed using Dynamo by Vald branded dynamometer. The results will be reported in Newtons.
Measured: pre-intervention, immediately after the intervention
balance assessment
berg balance scale
Measured: pre-intervention, immediately after the intervention
gait
gait speed, cadence
Measured: pre-intervention, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start10 Jan 2024
- Primary completion25 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Hallucis Longus Muscle Strength in Elderly IndividualsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hüseyin Gerdan, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887478
- Sponsor's protocol ID
- 2024049
- Status last verified
- Jan 2025
- First submitted
- 8 Mar 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Balance-Gait Parameters and Fall Effect of Flexor Hallucis Longus Muscle Strengthening Training in Geriatric Group
- ClinicalTrials.gov ID
- NCT06887478
- Acronym / sponsor ID
- 2024049
- Keywords
- elderly, flexor hallucis longus, balance, gait, falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 20 Mar 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.
Examination of Balance-Gait Parameters and Fall Effect of Flexor Hallucis Longus Muscle Strengthening Training in Geriatric Group It has been demonstrated that the reduction in the strength of the toe flexor muscles is an independent indicator of falls in geriatric individuals. However, the extent of this strength loss and the effects of strengthening training programs on balance, gait parameters, and falls are not well understood.
Objective: The aim is to investigate whether a progressive resistance exercise program, focusing specifically on the flexor hallucis longus (FHL) muscle, can improve toe flexor strength and influence gait, balance, and falls in geriatric individuals.
Materials and Methods: Individuals over the age of 65 who are willing to participate in the study will be included. The participants will be divided into three groups: individual exercise group, home exercise group, and control group. Individuals who are unable to walk independently, have severe musculoskeletal disorders, have hallux rigidus deformity, suffer from orthostatic hypotension, have difficulty understanding instructions, or have diabetic neuropathy will be excluded from the study. After obtaining socio-demographic information from the participants, anthropometric measurements will be taken. Toe grip strength will be assessed using a digital dynamometer, and the strength of the intrinsic foot muscles and lower extremity antigravity muscles will also be measured using a digital dynamometer. Balance parameters will be evaluated using the Berg Balance Scale, Functional Reach Test, Timed Up and Go Test, while gait parameters will be assessed using the 10-meter walk test and Tinetti Gait Scale. Fall parameters will be assessed by the Falls Efficacy Scale and fall frequency.
The collected data will be analyzed using SPSS (Statistical Package for Social Sciences) software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-Assisted Isolated FHL Strengthening Exercise Group | Experimental | Other: ExerciseThe intervention for the "Physiotherapist-Assisted Isolated FHL Strengthening Exercise Group (FHL-SET)" will consist of physiotherapist-guided, isolated strengthening exercises specifically targeting the Flexor Hallucis Longus (FHL) muscle. Participants will engage in exercises designed to isolate and strengthen the FHL muscle through controlled and progressive resistance. Sessions will occur three times a week for 8 weeks, with the physiotherapist providing individualized adjustments and ensuring proper technique and progression. |
| Home-Based Foot and Ankle Strengthening Exercise Training Group | Experimental | Other: ExerciseAfter the initial assessments, the participants in this group will receive home-based foot and ankle strengthening exercises three times a week for 8 weeks. They will be monitored weekly using an exercise log. The Home-Based Exercise Group (EvT-KE) will be taught general foot exercises without progression in resistance. These exercises include ankle rotations, toe raises, toe lifts, rolling a ball under the foot for 2 minutes, picking up marbles with toes, towel collection exercises, and foot shortening exercises. |
| Control Group | No intervention | –For the Control Group, initial and final assessments will be conducted at the beginning of the study and at the end of 8 weeks. No exercise program will be provided during this period. After the study, necessary exercises and recommendations will be given. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Individuals over the age of 65,
- Individuals who do not have hearing or speech problems,
- Individuals who do not have any neurological, orthopedic or visual problems that would prevent walking (can walk 10 meters independently)
- Individuals who score 24 points and above in the Mini Mental Test evaluation.
Key exclusion criteria (5 listed)
- Those who cannot walk independently,
- Those with serious musculoskeletal system disorders,
- Those with hallux rigidus deformity,
- Those with orthostatic hypotension,
- Those who have difficulty understanding instructions and those with diabetic neuropathy.
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 |
|---|---|---|
| ExerciseA progressive resistance exercise program focusing on strengthening the flexor hallucis longus (FHL) muscle in elderly participants. | Other | Home-Based Foot and Ankle Strengthening Exercise Training Group, Physiotherapist-Assisted Isolated FHL Strengthening Exercise Group |
Primary outcome
Muscle Strength Measurement
Time frame: pre-intervention, immediately after the intervention
Flexor hallucis longus strength and toe grip strength will be assessed using Dynamo by Vald branded dynamometer. The results will be reported in Newtons.
balance assessment
Time frame: pre-intervention, immediately after the intervention
berg balance scale
gait
Time frame: pre-intervention, immediately after the intervention
gait speed, cadence
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 30 Oct 2026.
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 Exercise in people with Flexor Hallucis Longus Muscle Strength in Elderly Individuals, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
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 5 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 30 Oct 2026. 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 Turkey (Türkiye). 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?
Muscle Strength Measurement (time frame: pre-intervention, immediately after the intervention). The study lists 3 primary outcomes in all. 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 30 Oct 2026.