ElderlyFONCT06615089
Effect Of Balance Training With Foot Orthosis On Falling In Elderly
A study testing balance training and orthotic prescription in people with Elderly, run by Cairo University.
Trial summary
this study will be conducted to investigate effect of balance training with foot orthosis on falling in elderly. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Elderly
- What is being tested?
- balance training and orthotic prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 28 Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
this study will be conducted to investigate effect of balance training with foot orthosis on falling in elderly.
Read the 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.
- Conditions
- Elderly
- Being tested
- balance training, orthotic prescription
- Keywords
- balance trainig, foot orthosis, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance trainingOther
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
orthotic prescriptionOther
the elderly patients will receive Insoles inside the subjects' own regular shoes
| Study group | Role | What they receive |
|---|---|---|
| balance training | Experimental | thirty elderly patients will receive balance training and orthotic prescription for four months Receives: Other: balance training; Other: orthotic prescription |
| orthotic prescription | Active comparator | thirty elderly patients will receive orthotic prescription for four months Receives: Other: orthotic prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
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
Measured: up to four months
Secondary outcomes (3)
gait assessment
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
Measured: up to four months
balance deficit
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.
Measured: up to four months
gait and balance assessment
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
Measured: up to four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- balance training and foot orthosis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youmn Nabil Saad Zaghloul Hafez, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615089
- Sponsor's protocol ID
- P.T.REC/012/004445
- Acronym
- FO
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Balance Training With Foot Orthosis On Falling In Elderly
- ClinicalTrials.gov ID
- NCT06615089
- Acronym / sponsor ID
- FO / P.T.REC/012/004445
- Conditions
- Elderly
- Keywords
- balance trainig, foot orthosis, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 26 Sep 2024 (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.
this study will be conducted to investigate effect of balance training with foot orthosis on falling in elderly.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- balance training and foot orthosis
| Arm | Type | Receives |
|---|---|---|
| balance training | Experimental | Other: balance training, Other: orthotic prescriptionthirty elderly patients will receive balance training and orthotic prescription for four months |
| orthotic prescription | Active comparator | Other: orthotic prescriptionthirty elderly patients will receive orthotic prescription for four months |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Age 65-75years
- Both gender
- Body mass index 25-29.9 kg/m2
- All participants will use foot orthosis
- Clinically and medically stable patients
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| balance trainingthe 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 | balance training |
| orthotic prescriptionthe elderly patients will receive Insoles inside the subjects' own regular shoes | Other | balance training, orthotic prescription |
Primary outcome
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
3 secondary outcomes
gait assessment
Time frame: up to four months
balance deficit
Time frame: up to four months
gait and balance assessment
Time frame: up to four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing balance training and orthotic prescription in people with Elderly, run by Cairo University.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact youmn N saad zaghloul, master (01025354831, youmnhafez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: up to four 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 26 Sep 2024.