NCT06887478

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 8, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

elderlyflexor hallucis longusbalancegaitfalls

Outcome Measures

Primary Outcomes (3)

  • 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.

    pre-intervention, immediately after the intervention

  • balance assessment

    berg balance scale

    pre-intervention, immediately after the intervention

  • gait

    gait speed, cadence

    pre-intervention, immediately after the intervention

Study Arms (3)

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.

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.

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.

Interventions

A progressive resistance exercise program focusing on strengthening the flexor hallucis longus (FHL) muscle in elderly participants.

Home-Based Foot and Ankle Strengthening Exercise Training GroupPhysiotherapist-Assisted Isolated FHL Strengthening Exercise Group

Eligibility Criteria

Age65 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsover 65 years old
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atakum Nursing Home, Elderly Care and Rehabilitation Center

Samsun, Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD thesis student

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 20, 2025

Study Start

January 10, 2025

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations