Postural BalanceNCT07824336
Effect of Total Contact Insoles Intervention on Balance Ability for the Elderly
A study testing Custom-Made Total Contact Insoles in people with Postural Balance and Gait, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This randomized controlled trial evaluated the effects of custom-made total contact insoles on postural control, functional mobility, walking performance, and plantar pressure characteristics in institutionalized older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postural Balance, Gait, Functional Mobility
- What is being tested?
- Custom-Made Total Contact Insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2025to 21 Nov 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
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older.
- No previous use of individually fabricated custom-made total contact insoles.
- Able to walk independently in daily life.
- Willing to wear the assigned insoles during daily activities and complete follow-up assessments.
- Able to follow simple instructions, understand the purpose of the study, and comply with the study procedures.
Who cannot join
- Neurological disorders affecting gait or balance, such as Parkinson's disease, stroke, poliomyelitis, or lower-limb nerve injury.
- Diabetes mellitus with peripheral neuropathy.
- History of lower-limb fracture or joint replacement affecting lower-limb length.
- Osteoporosis or vertebral compression fracture.
- Foot, ankle, or knee deformity, arthritis-related pain, or soft-tissue pain that interfered with study testing.
- Visual or hearing impairment affecting test safety or comprehension of instructions.
- History of psychiatric illness or substance misuse.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial evaluated the effects of custom-made total contact insoles on postural control, functional mobility, walking performance, and plantar pressure characteristics in institutionalized older adults. Participants were randomly assigned to either an intervention group receiving custom-made total contact insoles or a control group continuing to use their usual insoles. The intervention period was 8 weeks, with assessments conducted at baseline, after initial use of the assigned insole condition, at 4 weeks, and at 8 weeks. Outcomes included static postural control, functional mobility assessed using the instrumented Timed Up and Go test, walking performance during a 10-meter walk test, and plantar pressure characteristics measured during walking. The study aimed to characterize changes in postural control, functional mobility, gait-related function, and plantar loading associated with custom-made total contact insole use over the intervention period.
Read the detailed description
The study was designed as a two-group randomized controlled trial involving institutionalized older adults residing in a veterans' residential care facility. Eligible participants were aged 65 years or older, were able to walk independently in daily life, had no previous experience using individually fabricated custom-made total contact insoles, were willing to use the assigned insole condition during daily activities, and were able to understand and comply with the study procedures. Participants were randomly assigned to either an intervention group or a control group. Participants in the intervention group received individually customized total contact insoles fabricated according to each participant's foot morphology and arch characteristics. Participants in the control group continued using their usual personal insoles. The assigned insole condition was maintained throughout the 8-week intervention period. Assessments were conducted at baseline, after initial use of the assigned insole condition, at 4 weeks, and at 8 weeks. Static postural control was assessed using force-platform measurements. Functional mobility and trunk movement characteristics were evaluated using an instrumented Timed Up and Go test. Walking performance was assessed during a 10-meter walk test using a wearable gait analysis system. During the 10-meter walk test, plantar pressure was simultaneously recorded using an in-shoe plantar pressure measurement system. Plantar pressure analysis included peak plantar pressure, timing of peak plantar pressure within the gait cycle, pressure-time integral, and contact area. Measurements were evaluated across plantar regions including the heel, midfoot, individual metatarsal regions, toe regions, and the total foot. Plantar pressure analyses were performed using data from the participant's dominant foot.
- Conditions
- Postural Balance, Gait, Functional Mobility
- Being tested
- Custom-Made Total Contact Insoles
- Keywords
- custom-Made Total Contact Insoles, Older Adults, Postural Control, Timed Up and Go Test, Gait Analysis, Walking Speed, Plantar Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-Made Total Contact InsolesDevice
Individually customized total contact insoles were fabricated by trained orthotic professionals according to each participant's foot morphology. The insoles were designed to support the medial longitudinal arch, lateral longitudinal arch, and transverse arch, and to increase contact between the plantar surface of the foot and the insole. After the baseline assessment, participants wore the custom-made total contact insoles and walked at least 320 steps for familiarization before the immediate post-intervention assessment. Participants were instructed to wear the insoles for at per day during the 8-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Custom-Made Total Contact Insole Group | Experimental | Participants assigned to this group received individually customized total contact insoles and wore them during the 8-week intervention period. After the baseline assessment, participants wore the insoles and walked at least 320 steps for familiarization before the immediate post-intervention assessment. Participants were instructed to wear the insoles for at least per day during the intervention period. Receives: Device: Custom-Made Total Contact Insoles |
| Control Group | No intervention | Participants assigned to the control group continued using their usual insoles and did not receive the custom-made total contact insole intervention during the 8-week study period. Footwear from participants in both groups was handled using the same procedure to maintain participant masking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Postural Control During Quiet Standing
Static postural control was assessed using dual Hawkin Dynamics force platforms during three 30-second eyes-open quiet-standing trials. Outcomes included mediolateral and anteroposterior sway length, total sway length, sway range, and average sway velocity, calculated separately for the left and right sides to characterize postural stability and directional control during quiet standing.
Measured: Baseline, immediately after initial insole use, Week 4, and Week 8
Timed Up and Go Total Time
Functional mobility and movement control were assessed using the Timed Up and Go test with a G-Walk wearable inertial sensor. Outcomes included total completion time and phase durations for Sit-to-Stand, Forward Gait, Mid Turning, Return Gait, End Turning, and Stand-to-Sit. Maximum and minimum trunk accelerations in the vertical, mediolateral, and anteroposterior directions, peak trunk flexion and extension angles and ranges of motion during Sit-to-Stand and Stand-to-Sit, and mean and peak trunk angular velocities during turning phases were also recorded.
Measured: Baseline, immediately after initial insole use, Week 4, and Week 8
Gait Performance During the 10-Meter Walk Test
Gait performance was assessed during a 10-meter walk test using the G-Walk wearable inertial sensor positioned over the fifth lumbar vertebra. Participants walked at their natural or self-selected speed, and two trials were performed. Outcomes included cadence, gait speed, bilateral symmetry index, left and right stride cycle time, stride length, stride length normalized to height, stance phase, swing phase, first double-support phase, single-support phase, propulsion index, walking quality index, and pelvic tilt, obliquity, and rotation symmetry indices.
Measured: Baseline, immediately after initial insole use, Week 4, and Week 8
Secondary outcomes (1)
Plantar Pressure During Walking
Peak plantar pressure (kPa) was measured for the dominant foot using the F-Scan in-shoe plantar pressure system during the 10-meter walk test. Measurements were obtained for the total foot and predefined plantar regions, including the heel, midfoot, metatarsal regions, and toe regions.
Measured: Baseline, after initial use of the assigned insole condition, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start15 Jul 2025
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies 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
- Model description
- Participants were randomly assigned to either a custom-made total contact insole intervention group or a control group and were followed in parallel over an 8-week intervention period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824336
- Sponsor's protocol ID
- 2025-06-007C
- Other IDs
- 114VACS-004
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Contact Insoles Intervention on Balance Ability for the Elderly
- ClinicalTrials.gov ID
- NCT07824336
- Acronym / sponsor ID
- 2025-06-007C
- Conditions
- Postural Balance, Gait, Functional Mobility
- Keywords
- custom-Made Total Contact Insoles, Older Adults, Postural Control, Timed Up and Go Test, Gait Analysis, Walking Speed, Plantar Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 17 Sep 2026 (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 randomized controlled trial evaluated the effects of custom-made total contact insoles on postural control, functional mobility, walking performance, and plantar pressure characteristics in institutionalized older adults. Participants were randomly assigned to either an intervention group receiving custom-made total contact insoles or a control group continuing to use their usual insoles. The intervention period was 8 weeks, with assessments conducted at baseline, after initial use of the assigned insole condition, at 4 weeks, and at 8 weeks. Outcomes included static postural control, functional mobility assessed using the instrumented Timed Up and Go test, walking performance during a 10-meter walk test, and plantar pressure characteristics measured during walking. The study aimed to characterize changes in postural control, functional mobility, gait-related function, and plantar loading associated with custom-made total contact insole use over the intervention period.
Detailed description
The study was designed as a two-group randomized controlled trial involving institutionalized older adults residing in a veterans' residential care facility. Eligible participants were aged 65 years or older, were able to walk independently in daily life, had no previous experience using individually fabricated custom-made total contact insoles, were willing to use the assigned insole condition during daily activities, and were able to understand and comply with the study procedures. Participants were randomly assigned to either an intervention group or a control group. Participants in the intervention group received individually customized total contact insoles fabricated according to each participant's foot morphology and arch characteristics. Participants in the control group continued using their usual personal insoles. The assigned insole condition was maintained throughout the 8-week intervention period. Assessments were conducted at baseline, after initial use of the assigned insole condition, at 4 weeks, and at 8 weeks. Static postural control was assessed using force-platform measurements. Functional mobility and trunk movement characteristics were evaluated using an instrumented Timed Up and Go test. Walking performance was assessed during a 10-meter walk test using a wearable gait analysis system. During the 10-meter walk test, plantar pressure was simultaneously recorded using an in-shoe plantar pressure measurement system. Plantar pressure analysis included peak plantar pressure, timing of peak plantar pressure within the gait cycle, pressure-time integral, and contact area. Measurements were evaluated across plantar regions including the heel, midfoot, individual metatarsal regions, toe regions, and the total foot. Plantar pressure analyses were performed using data from the participant's dominant foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either a custom-made total contact insole intervention group or a control group and were followed in parallel over an 8-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Custom-Made Total Contact Insole Group | Experimental | Device: Custom-Made Total Contact InsolesParticipants assigned to this group received individually customized total contact insoles and wore them during the 8-week intervention period. After the baseline assessment, participants wore the insoles and walked at least 320 steps for familiarization before the immediate post-intervention assessment. Participants were instructed to wear the insoles for at least per day during the intervention period. |
| Control Group | No intervention | –Participants assigned to the control group continued using their usual insoles and did not receive the custom-made total contact insole intervention during the 8-week study period. Footwear from participants in both groups was handled using the same procedure to maintain participant masking. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged 65 years or older.
- No previous use of individually fabricated custom-made total contact insoles.
- Able to walk independently in daily life.
- Willing to wear the assigned insoles during daily activities and complete follow-up assessments.
- Able to follow simple instructions, understand the purpose of the study, and comply with the study procedures.
Key exclusion criteria (7 listed)
- Neurological disorders affecting gait or balance, such as Parkinson's disease, stroke, poliomyelitis, or lower-limb nerve injury.
- Diabetes mellitus with peripheral neuropathy.
- History of lower-limb fracture or joint replacement affecting lower-limb length.
- Osteoporosis or vertebral compression fracture.
- Foot, ankle, or knee deformity, arthritis-related pain, or soft-tissue pain that interfered with study testing.
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 |
|---|---|---|
| Custom-Made Total Contact InsolesIndividually customized total contact insoles were fabricated by trained orthotic professionals according to each participant's foot morphology. The insoles were designed to support the medial longitudinal arch, lateral longitudinal arch, and transverse arch, and to increase contact between the plantar surface of the foot and the insole. After the baseline assessment, participants wore the custom-made total contact insoles and walked at least 320 steps for familiarization before the immediate post-intervention assessment. Participants were instructed to wear the insoles for at per day during the 8-week intervention period. | Device | Custom-Made Total Contact Insole Group |
Primary outcome
Static Postural Control During Quiet Standing
Time frame: Baseline, immediately after initial insole use, Week 4, and Week 8
Static postural control was assessed using dual Hawkin Dynamics force platforms during three 30-second eyes-open quiet-standing trials. Outcomes included mediolateral and anteroposterior sway length, total sway length, sway range, and average sway velocity, calculated separately for the left and right sides to characterize postural stability and directional control during quiet standing.
Timed Up and Go Total Time
Time frame: Baseline, immediately after initial insole use, Week 4, and Week 8
Functional mobility and movement control were assessed using the Timed Up and Go test with a G-Walk wearable inertial sensor. Outcomes included total completion time and phase durations for Sit-to-Stand, Forward Gait, Mid Turning, Return Gait, End Turning, and Stand-to-Sit. Maximum and minimum trunk accelerations in the vertical, mediolateral, and anteroposterior directions, peak trunk flexion and extension angles and ranges of motion during Sit-to-Stand and Stand-to-Sit, and mean and peak trunk angular velocities during turning phases were also recorded.
Gait Performance During the 10-Meter Walk Test
Time frame: Baseline, immediately after initial insole use, Week 4, and Week 8
Gait performance was assessed during a 10-meter walk test using the G-Walk wearable inertial sensor positioned over the fifth lumbar vertebra. Participants walked at their natural or self-selected speed, and two trials were performed. Outcomes included cadence, gait speed, bilateral symmetry index, left and right stride cycle time, stride length, stride length normalized to height, stance phase, swing phase, first double-support phase, single-support phase, propulsion index, walking quality index, and pelvic tilt, obliquity, and rotation symmetry indices.
1 secondary outcome
Plantar Pressure During Walking
Time frame: Baseline, after initial use of the assigned insole condition, 4 weeks, and 8 weeks
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Custom-Made Total Contact Insoles in people with Postural Balance and Gait, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 5 inclusion and 7 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 9 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 Taiwan. 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?
Static Postural Control During Quiet Standing (time frame: Baseline, immediately after initial insole use, Week 4, and Week 8). 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 9 Oct 2026.