- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06887478
Flexor Hallucis Longus Training and Balance-Gait in Geriatrics
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Samsun, Turkey, 55200
- Atakum Nursing Home, Elderly Care and Rehabilitation Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physiotherapist-Assisted Isolated FHL Strengthening Exercise Group
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.
|
A progressive resistance exercise program focusing on strengthening the flexor hallucis longus (FHL) muscle in elderly participants.
|
|
Experimental: Home-Based Foot and Ankle Strengthening Exercise Training Group
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.
|
A progressive resistance exercise program focusing on strengthening the flexor hallucis longus (FHL) muscle in elderly participants.
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
pre-intervention, immediately after the intervention
|
|
balance assessment
Time Frame: pre-intervention, immediately after the intervention
|
berg balance scale
|
pre-intervention, immediately after the intervention
|
|
gait
Time Frame: pre-intervention, immediately after the intervention
|
gait speed, cadence
|
pre-intervention, immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024049 (Registry Identifier: Milk Temperature and NEC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Flexor Hallucis Longus Muscle Strength in Elderly Individuals
-
University of North Carolina, Chapel HillRecruitingFrailty | Sarcopenia | Muscle Strength | Nutrition Assessment | Risk Assessment | Hand Strength | Post Operative Complications | Elderly (People Aged 65 or More) | Sarcopenia in ElderlyUnited States
-
University of UdineEnrolling by invitationSarcopenia | Nutritional Intervention | Quality of Life Outcomes | Sarcopenia in Elderly | Microbiome Analysis | Biomarkers / Blood | Muscle Mass and StrengthItaly
-
Nuritas LtdMedifood Hungary Innovation KftRecruitingPhysical Function | Protein Supplementation | Strength | Malnourished | Sarcopenia in Elderly | Muscle MassHungary
-
Biruni UniversityÇanakkale Onsekiz Mart UniversityNot yet recruitingCardiovascular Diseases | Hypertension | Diabetes Mellitus | The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly Individuals
Clinical Trials on Exercise
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Aksaray University Training and Research HospitalCompletedExercise Training | Lactate Blood Increase | Cognitive Functions | BDNFTurkey (Türkiye)
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting
-
University of Missouri-ColumbiaCompleted
-
University of AlcalaCompletedMyofascial Pain | Myofascial Pain Syndrome | Post Needling Soreness | Myofascial Trigger Point PainSpain
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Bayero University Kano, NigeriaCompletedChronic Low Back PainNigeria
-
University College CorkRecruitingDepressive Disorder, MajorIreland