Effect Of Balance Training With Foot Orthosis On Falling In Elderly (FO)

September 24, 2024 updated by: Youmn Nabil Saad Zaghloul Hafez, Cairo University
this study will be conducted to investigate effect of balance training with foot orthosis on falling in elderly.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The concept of physiology of ageing implies that a series of complex events occur which ultimately lead to a progressive reduction in function of all organ systems. This process, also called "homeostenosis," is influenced by gene variations and differences in exposure to environmental factors .Reduction in muscle strength and coordination of the lower extremities accompanied by decreased gait assurance and balance control are the result of a physical deterioration in an older body. Together with decreased cognitive functions, these impairments lead to a higher risk of falling among the elderly. The foot is the first point of contact between the body and the external environment, and it plays an important role in postural sway. Its plantar mechanical receptors provide spatial and temporal information about contact pressures and shear forces resulting from body movement being a valuable feedback mechanism to the postural control system. Interventions to optimize sensory information from plantar sole such as vibration stimuli, customized foot orthoses, textured insoles, and sandals with textured insoles and magnetic insoles have been tested before, some of them showing balance improvement .Sixty elderly patients will be allocated randomly to two groups; group 1 will receive balance training program beside orthotic prescription and group 2 will receive orthotic prescription alone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 65-75years
  • Both gender
  • Body mass index 25-29.9 kg/m2
  • All participants will use foot orthosis
  • Clinically and medically stable patients
  • having a Berg Balance Scale (BBS) score between 35 and 45
  • Scored 19-21 will be regarded as being at moderate risk of falling,
  • Scored 19-23 in the Tinetti tool score
  • Scored more than 13.5 sec in timed up-and-go test

Exclusion Criteria:

  • Bedridden subjects.
  • Previous vestibular diseases, central nervous system pathologies (such as stroke, dementia, Parkinson, etc.).
  • Previous diagnosis of peripheral neuropathy.
  • current use of medications affect the result of the study
  • Use of insoles in the last month
  • Previous history of foot surgery, and amputation of the lower limbs.
  • severe foot deformity (not able to wear regular shoes), difficulty in adapting insoles inside his/her own shoes,
  • Patient with life threatening disorders as renal failure, myocardial infarction.
  • Patients who suffering from myasthenia gravis, hyperthyroidism, haemorrhage, acute viral disease, acute tuberculosis, mental disorders or those with pacemakers.
  • Un controlled diabetes, hypertension and smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: balance training
thirty elderly patients will receive balance training and orthotic prescription for four months
Other: balance training
the elderly patients will receive balance training in the form of proprioceptive and vestibular training components. proprioceptive training include Standing static balance, lateral weight transfer, Lateral weight transfer near to chair, tandem closed eyes, walking on toes, Postural control using ball. Vestibular training in the form of Balance with head movement, seated lateral step in addition to Insoles inside the subjects' own regular shoes
Other: orthotic prescription
the elderly patients will receive Insoles inside the subjects' own regular shoes
Active Comparator: orthotic prescription
thirty elderly patients will receive orthotic prescription for four months
Other: orthotic prescription
the elderly patients will receive Insoles inside the subjects' own regular shoes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
balance
Time Frame: up to four months
The Berg Balance Scale (BBS) will be used to assess balance. it measure the ability of a subject to maintain balance while performing 14 movements required in everyday activities . Scoring is based on an ordinal 5-point scale of 0 to 4. A score of 0 is given if the subject is unable to complete the task and a 4 is given if the subject is able to complete the task unassisted. The maximum possible score is 56
up to four months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
gait assessment
Time Frame: up to four months
The Dynamic gait index was primarily developed to assess a subject's ability to modify gait in response to changing task demands.The eight abilities assessed are: steady-state walking, walking while changing gait speed, walking while moving the head vertically and horizontally, walking while stepping over and around an obstacle, pivoting during walking, and stair climbing. The items of the DGI are graded on a four-point scale from 'normal performance' (3) to 'severely impaired' (0), yielding a maximum score of 24 points
up to four months
balance deficit
Time Frame: up to four months
The Timed "up and go" test is performed in the following way. The patient will sit on a standard arm chair (seat height 46cm as in the original setting, arm height 67cm) with his or her back against the chair, arms resting on the chair's arms and walking aid at hand. Patients will wear their regular footwear and will use their customary walking aids. After the patient will state that he or she is ready, the test will start. On the word "go" the patient will stand, will walk to a line on the floor 3m away (on a standard short-piled carpet with a length of 4m and width of lm), turns, will walk back to the chair, and will sit down again.
up to four months
gait and balance assessment
Time Frame: up to four months
The Tinetti Assessment Tool is a simple test that measures a participant's gait and balance. The participant performs a total of 16 tasks (during 9 tests the researcher assesses the balance of the participant and during 7 subsequent tests the researcher assesses the gait of the participant). Scoring of the Tinetti Assessment Tool is done on a two or 3-point ordinal scale (depending on the task) with a range of 0 to 1 or 0 to 2. A score of 0 represents the most impairment, while a score of 1 or 2 represents independence
up to four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004445

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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