Older Adults, BalanceNCT02821091
Biomechanics Research in the Effects of Interactive Dynamic Balance Training on Postural and Gait Control in Older Adults
A study testing Interactive Dynamic Balance Training in people with Older Adults, Balance, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aim 1: Determine the relationships between muscle quality and balance performance as well as any association with fracture and fall history in older adults. Muscle quality will be calculated from the information of muscle strength and body composition (strength/lean muscle mass). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Balance
- What is being tested?
- Interactive Dynamic Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Apr 2015to 24 Jan 2017
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For control young adults group:
- able to stand and walk for 5 minutes independently without assistant
- aging between 20 and 59 years old
- For older adults group:
- able to stand and walk for 5 minutes independently without assistant
- aging between 60 and 80 years old;
Who cannot join
- pre-existing major lower-extremity pathology (e.g., Chronic ankle instability or severe osteoarthritis)
- neurological disorders or balance difficulties (e.g., Vertigo, poor vision, dizziness, stroke, or epilepsy) that would prevent standing for the duration of the testing procedures without the aid of an assistive device
- health conditions (e.g., Heart disease, uncontrolled hypertension, chronic obstructive pulmonary diseases) that would exclude participation in a balance exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Aim 1: Determine the relationships between muscle quality and balance performance as well as any association with fracture and fall history in older adults.
Muscle quality will be calculated from the information of muscle strength and body composition (strength/lean muscle mass). The investigators will compute the joint torque during functional activates using biomechanical data from the 3-D motion analysis, whereas the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis (BIA). Clinical and functional assessments for balance performance will also be conducted. Fracture and fall history prior to the testing will be recorded retrospectively.
Read more
Aim 2: Identify the relationships between force usages during balance perturbation in older adults.
Lateral and forward/backward perturbation while walking will be used to elicit balance recovery responses. The degree of necessary joint force and how this relates to a person's functional capacity at specific joint levels will be determined by the torque demand to capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a joint-specific unified scalar quantity representing the balance recovery demand normalized by the maximum muscle strength capacity of an individual. It would indicate whether a person can recover balance and to what extent of his/her maximum capacity is taxed.
Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized strengthening and balance training program on improving balance performance in older adults.
Personalized strengthening and balance training exercise will be personalized based on the results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and split-belt balance perturbation instrumented treadmill. The exercise group will receive training 2 times a week for 2 months and the age-matched control group will maintain their usual daily life activities. All assessments will be performed at baseline, and 1 week after training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following the training period.
Read the detailed description
Aging populations has become a global issue. Fall is a prevalent concern among aging adults that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this aging population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. Older adults often combining with muscles weakness (sarcopenia), bone loss (osteoporosis) and lead to increased spine kyphosis causing vertebral fractures and poor balance control. Therefore, the long-term objectives of this work are to prevent fall in older adults by improving the function of degenerative muscles. The proposed research can provide needed information regarding the processes of balance control in this aging population, and can potentially be applied to individuals with poor balance who at high risk of fall. Three specific aims for this 3 years research project are described as follow:
Aim 1: Determine the relationships between muscle quality and balance performance as well as any association with fracture and fall history in older adults.
Muscle quality will be calculated from the information of muscle strength and body composition (strength/lean muscle mass). The investigators will compute the joint torque during functional activates using biomechanical data from the 3-D motion analysis, whereas the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis (BIA). Clinical and functional assessments for balance performance will also be conducted. Fracture and fall history prior to the testing will be recorded retrospectively.
Aim 2: Identify the relationships between force usages during balance perturbation in older adults.
Lateral and forward/backward perturbation while walking will be used to elicit balance recovery responses. The degree of necessary joint force and how this relates to a person's functional capacity at specific joint levels will be determined by the torque demand to capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a joint-specific unified scalar quantity representing the balance recovery demand normalized by the maximum muscle strength capacity of an individual. It would indicate whether a person can recover balance and to what extent of his/her maximum capacity is taxed.
Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized strengthening and balance training program on improving balance performance in older adults.
Personalized strengthening and balance training exercise will be personalized based on the results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and split-belt balance perturbation instrumented treadmill. The exercise group will receive training 2 times a week for 2 months and the age-matched control group will maintain their usual daily life activities. All assessments will be performed at baseline, and 1 week after training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following the training period.
Translational research of this nature will contribute necessary information on the critical factors of balance control in older adults. The research will also test clinical innovations of exercise training to improve the long-term prognosis in this vulnerable aging population group. The unique contribution of the proposed research lies in the integration of an explicit physical examination and biomechanical approach to a relevant clinical problem within a translational model. The findings will provide a new paradigm of treatment approaches for balance control and will reduce the risk of falling and fracture. This research can potentially be applied to individuals with poor balance who are at high risk of falling.
- Conditions
- Older Adults, Balance
- Being tested
- Interactive Dynamic Balance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Dynamic Balance TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Control young adults | No intervention | Healthy adults, age between 20 to 59 yeas old |
| Control old adults | No intervention | Healthy adults, age between 60 to 80 yeas old |
| Exercise old adults | Experimental | Healthy adults, age between 60 to 80 yeas old received interactive dynamic balance training Receives: Other: Interactive Dynamic Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start16 Apr 2015
- Primary completion26 Apr 2016
- Study completion24 Jan 2017
Why it stopped: Limitaiotn of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults, BalanceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Hsu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821091
- Sponsor's protocol ID
- 201501039RINC
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2016
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanics Research in the Effects of Interactive Dynamic Balance Training on Postural and Gait Control in Older Adults
- ClinicalTrials.gov ID
- NCT02821091
- Acronym / sponsor ID
- 201501039RINC
- Conditions
- Older Adults, Balance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limitaiotn of financial support
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Apr 2015 (actual)
- Primary completion
- 26 Apr 2016 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- 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.
Aim 1: Determine the relationships between muscle quality and balance performance as well as any association with fracture and fall history in older adults.
Muscle quality will be calculated from the information of muscle strength and body composition (strength/lean muscle mass). The investigators will compute the joint torque during functional activates using biomechanical data from the 3-D motion analysis, whereas the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis (BIA). Clinical and functional assessments for balance performance will also be conducted. Fracture and fall history prior to the testing will be recorded retrospectively.
Aim 2: Identify the relationships between force usages during balance perturbation in older adults.
Lateral and forward/backward perturbation while walking will be used to elicit balance recovery responses. The degree of necessary joint force and how this relates to a person's functional capacity at specific joint levels will be determined by the torque demand to capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a joint-specific unified scalar quantity representing the balance recovery demand normalized by the maximum muscle strength capacity of an individual. It would indicate whether a person can recover balance and to what extent of his/her maximum capacity is taxed.
Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized strengthening and balance training program on improving balance performance in older adults.
Personalized strengthening and balance training exercise will be personalized based on the results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and split-belt balance perturbation instrumented treadmill. The exercise group will receive training 2 times a week for 2 months and the age-matched control group will maintain their usual daily life activities. All assessments will be performed at baseline, and 1 week after training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following the training period.
Detailed description
Aging populations has become a global issue. Fall is a prevalent concern among aging adults that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this aging population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. Older adults often combining with muscles weakness (sarcopenia), bone loss (osteoporosis) and lead to increased spine kyphosis causing vertebral fractures and poor balance control. Therefore, the long-term objectives of this work are to prevent fall in older adults by improving the function of degenerative muscles. The proposed research can provide needed information regarding the processes of balance control in this aging population, and can potentially be applied to individuals with poor balance who at high risk of fall. Three specific aims for this 3 years research project are described as follow:
Aim 1: Determine the relationships between muscle quality and balance performance as well as any association with fracture and fall history in older adults.
Muscle quality will be calculated from the information of muscle strength and body composition (strength/lean muscle mass). The investigators will compute the joint torque during functional activates using biomechanical data from the 3-D motion analysis, whereas the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis (BIA). Clinical and functional assessments for balance performance will also be conducted. Fracture and fall history prior to the testing will be recorded retrospectively.
Aim 2: Identify the relationships between force usages during balance perturbation in older adults.
Lateral and forward/backward perturbation while walking will be used to elicit balance recovery responses. The degree of necessary joint force and how this relates to a person's functional capacity at specific joint levels will be determined by the torque demand to capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a joint-specific unified scalar quantity representing the balance recovery demand normalized by the maximum muscle strength capacity of an individual. It would indicate whether a person can recover balance and to what extent of his/her maximum capacity is taxed.
Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized strengthening and balance training program on improving balance performance in older adults.
Personalized strengthening and balance training exercise will be personalized based on the results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and split-belt balance perturbation instrumented treadmill. The exercise group will receive training 2 times a week for 2 months and the age-matched control group will maintain their usual daily life activities. All assessments will be performed at baseline, and 1 week after training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following the training period.
Translational research of this nature will contribute necessary information on the critical factors of balance control in older adults. The research will also test clinical innovations of exercise training to improve the long-term prognosis in this vulnerable aging population group. The unique contribution of the proposed research lies in the integration of an explicit physical examination and biomechanical approach to a relevant clinical problem within a translational model. The findings will provide a new paradigm of treatment approaches for balance control and will reduce the risk of falling and fracture. This research can potentially be applied to individuals with poor balance who are at high risk of falling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control young adults | No intervention | –Healthy adults, age between 20 to 59 yeas old |
| Control old adults | No intervention | –Healthy adults, age between 60 to 80 yeas old |
| Exercise old adults | Experimental | Other: Interactive Dynamic Balance TrainingHealthy adults, age between 60 to 80 yeas old received interactive dynamic balance training |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- able to stand and walk for 5 minutes independently without assistant
- aging between 20 and 59 years old
- able to stand and walk for 5 minutes independently without assistant
- aging between 60 and 80 years old;
Key exclusion criteria (3 listed)
- pre-existing major lower-extremity pathology (e.g., Chronic ankle instability or severe osteoarthritis)
- neurological disorders or balance difficulties (e.g., Vertigo, poor vision, dizziness, stroke, or epilepsy) that would prevent standing for the duration of the testing procedures without the aid of an assistive device
- health conditions (e.g., Heart disease, uncontrolled hypertension, chronic obstructive pulmonary diseases) that would exclude participation in a balance exercise program.
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 |
|---|---|---|
| Interactive Dynamic Balance Training | Other | Exercise old adults |
Primary outcome
Timed Up and Go Test
Time frame: Up to 52 weeks
Results and safety
The study was stopped early (reason given: Limitaiotn of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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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.
Wei-Li Hsu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Dynamic Balance Training in people with Older Adults, Balance, run by National Taiwan University Hospital 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 May 2017. 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 was stopped early (reason given: Limitaiotn of financial support). Results are not available in the source record.
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?
Timed Up and Go Test (time frame: Up to 52 weeks). 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 8 May 2017.