SarcopeniaNCT05750888
Foot Core Exercise Program on Balance Control and Walking in Aged Sarcopenia
A study testing integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles and regular exercises for the elderly in people with Sarcopenia and Muscle Weakness, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
In modern society with an increasing aging population, recent literature has defined sarcopenia as a significant reduced mass and function of skeletal muscle with physical limitations due to aging. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Weakness, Walking, Difficulty
- What is being tested?
- integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles and regular exercises for the elderly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Aug 2022to 31 Jul 2023
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- the elderly with sarcopenia [1, 2] Age is more than 65 years with a medical diagnosis of sarcopenia Be able to independently stand and walk To meet the criteria of the definition of sarcopenia in the AWGS 2019 consensus update on sarcopenia diagnosis and treatment Be able to understand independently the participation consent in this research project
- Healthy elder individuals A neutral foot alignment: determined by measurement of the resting calcaneal stance position (RCSP: between 2˚of inversion and 2˚of eversion) and scores on the navicular drop (ND: between 5 and 9 mm) test.
- Foot Posture Index (FPI) Score is between 0 and 5. No pain in the lower limbs No history of lower limb injury that has affected function or caused the individual to seek previous medical or therapeutic intervention within 6 months
Who cannot join
- All groups not be able to sign the consent form for the participation Traumatic injury to lower limbs which impacted joint integrity and function (i.e., fractures) resulting in at least 1 interrupted day of desired physical activity Major neurological, cardiorespiratory, or circulatory disorders contribute to not being able to independently stand and walk.
- Recent intervention/management within the last 6 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
BuddhistTCGH
Hualien City, 97004
Chich-Haung Yang, PhD, +886-3-8565301 ext. 2496, r.chyang@gms.tcu.edu.tw
About this study
Official title: Effects of Integrated Foot Core Strengthening With Exerciser Device on Balance Control and Walking in the Elderly With and Without Sarcopenia
In modern society with an increasing aging population, recent literature has defined sarcopenia as a significant reduced mass and function of skeletal muscle with physical limitations due to aging. Clinically and experimentally, the foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Apparently, previous literature has shown that the intrinsic and extrinsic foot muscles have significantly reduced muscle morphology and muscle strength in the elderly compared to that of young healthy controls. How to effectively increase foot muscles using muscle-strengthening exercises will be a crucial issue for further research and clinical intervention in this population.
The intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g., the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program. Physiologically, the effects of integrated exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activate this kind of exercise efficiently and effectively is a key issue for employing these exercise interventions in the elderly with and without sarcopenia.
In this project, we will aim to employ the novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology in intrinsic and extrinsic foot muscles and foot posture before and after exercise intervention using sonographic imaging and foot posture index in the elderly with and without sarcopenia; second, we will investigate whether the immediate and persistent increase in balance control and level-walking after this therapeutic exercise with novel 3-D printing foot core exerciser.
Read the detailed description
In modern society with an increasing aging population, Asian Working Groups for Sarcopenia (AWSG) has defined sarcopenia as a significantly reduced mass and function of skeletal muscle with physical limitations due to aging. The prevalence in the globe has reported 5% - 25.7% of the elderly population and its associations are very high between daily activity limitations, physical limitations, and premature death. Clinically and experimentally, the foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Apparently, previous literature has shown that the intrinsic and extrinsic foot muscles have significantly reduced muscle morphology and muscle strength in the elderly compared to that of young healthy controls. How to effectively increase foot muscles using muscle-strengthening exercises will be a crucial issue for further research and clinical intervention in this population.
Anatomically, the intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g. the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program; Physiologically, the effects of integrated exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activate this kind of exercise efficiently and effectively is a key issue for employing these exercise interventions in the elderly with and without sarcopenia.
This project consists of two main parts - first, we will aim to employ the novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology in intrinsic and extrinsic foot muscles and foot posture before and after exercise intervention using sonographic imaging and foot posture index in the elderly with and without sarcopenia; second, we will investigate whether the immediate and persistent increase in balance control and level-walking after this therapeutic exercise with novel 3-D printing foot core exerciser. More importantly, we elucidate important clinical evidence-based information of long-term novel therapeutic exercise intervention for clinicians and health policymakers.
- Conditions
- Sarcopenia, Muscle Weakness, Walking, Difficulty, Balance Control
- Being tested
- integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles, regular exercises for the elderly
- Keywords
- Foot core system, Intrinsic foot muscle, Balance control, 3D printing, Gait
- Medical subject headings
- Sarcopenia, Muscle Weakness, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated exercise therapy with 3D printing exerciser for training intrinsic foot musclesBehavioural
Also called novel foot core exercise program
The therapeutic exercise program with a custom-made 3-D printing foot core exerciser, consisting of warm-up exercise, active range of motion in the foot and ankle joints, foot core system strengthening program using the 3D printing device, and stretching exercises for foot and ankle.
regular exercises for the elderlyBehavioural
Also called regular exercises
The regular exercise provided for the elderly in the dwelling community, including walking, simple aerobic exercises, stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | A novel-designed intrinsic foot muscle-strengthening exerciser using 3D printing techniques will be used in the experimental group. Receives: Behavioral: integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles |
| Experimental group 2 | Sham comparator | A regular exercise program will be provided in this group. Receives: Behavioral: regular exercises for the elderly |
| Control group | No intervention | There is no exercise or other intervention in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic imaging for cross-sectional area of muscles
The diagnostic ultrasound will be employed to detect the cross-sectional area (CSA) in specific foot intrinsic and extrinsic muscles, such as extrinsic muscle (Flexor digitorum longus FDL, Flexor Hallucis Longus FHL, and Peroneal longus PL) and intrinsic muscle ( Abductor Hallucis AbdH, Flexor Digitorum Brevis FDB and Flexor Hallucis Brevis FHB) CSA. The unit is cm2
Measured: changes among baseline, 4, 8 and 12 weeks
Sonographic imaging for the width and thickness of muscles
The diagnostic ultrasound will be employed to detect the width and thickness of specific foot intrinsic and extrinsic muscles, such as extrinsic muscles (FDL, FHL, and PER) and intrinsic muscle (AbdH, FDB, and FHB)width and thickness, and plantar fascia thickness (at the heel, mid and forefoot sites). The unit is cm (the width and length)
Measured: changes among baseline, 4, 8 and 12 weeks
Balance test for standing posture for area of sway trajectory in center of pressure (CoP) and center of mass (CoM)
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Measured: changes among baseline, 4, 8 and 12 weeks
Balance test for standing posture for the velocity of sway trajectory in center of pressure (CoP) and center of mass (CoM)
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm/sec.
Measured: changes among baseline, 4, 8 and 12 weeks
Balance test for standing posture for the length of sway trajectory in center of pressure (CoP)
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Measured: changes among baseline, 4, 8 and 12 weeks
Functional walking test for spatio-temporal parameters
Spatio-temporal parameters will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is m/sec.
Measured: changes among baseline, 4, 8 and 12 weeks
Functional walking test for joint kinematics in the lower limb
Joint kinematic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is degree.
Measured: changes among baseline, 4, 8 and 12 weeks
Functional walking test for joint kinetics in the lower limb
Joint kinetic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is Nm.
Measured: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in physical capacity in the elderly
Short Physical Performance Battery (0-12) questionnaires will be employed in this study. The unit is a unit on a scale.
Measured: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in functional capacity and falling condition in the elderly
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Falling questionnaire (0-10) will be employed in this study. The unit is a unit on a scale.
Measured: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in functional capacity and strength condition in the elderly
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Calf circumference (0-20). The unit is a unit on a scale.
Measured: changes among baseline, 4, 8 and 12 weeks
Secondary outcomes (4)
Clinical Questionnaires for assessment in cognitive capacity in the elderly
Mini-Mental State Examination (0-30) questionnaires will be employed in this study. The unit is a unit on a scale.
Measured: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in nutritional status in the elderly
Mini Nutritional Assessment - Short Form (0-11) will be employed in this study. The unit is a unit on a scale.
Measured: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in frail status in the elderly
Frail Index (0.0-1.0) will be employed in this study. The unit is a unit on a scale.
Measured: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in frailty condition the elderly
A clinical Frailty Scale (1-9) will be employed in this study. The unit is a unit on a scale.
Measured: changes among baseline, 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start30 Aug 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chich-Haung R Yang, PhD, Principal investigator, College of Medicine, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750888
- Sponsor's protocol ID
- P00001837
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
PubMed 32033882Dufour AB, Hannan MT, Murabito JM, Kiel DP, McLean RR. Sarcopenia definitions considering body size and fat mass are associated with mobility limitations: the Framingham Study. J Gerontol A Biol Sci Med Sci. 2013 Feb;68(2):168-74. doi: 10.1093/gerona/gls109. Epub 2012 Apr 13.
PubMed 22503991Kao SL, Hsiao ML, Wang JH, Chen CS, Chen SY, Shiau YJ, Yang CH. Effects of integrated intrinsic foot muscle exercise with foot core training device on balance and body composition among community-dwelling adults aged 60 and above. BMC Geriatr. 2024 May 7;24(1):403. doi: 10.1186/s12877-024-04945-y.
PubMed 38714957
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Integrated Foot Core Strengthening With Exerciser Device on Balance Control and Walking in the Elderly With and Without Sarcopenia
- ClinicalTrials.gov ID
- NCT05750888
- Acronym / sponsor ID
- P00001837
- Conditions
- Sarcopenia, Muscle Weakness, Walking, Difficulty, Balance Control
- Keywords
- Foot core system, Intrinsic foot muscle, Balance control, 3D printing, Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 2 Mar 2023 (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.
In modern society with an increasing aging population, recent literature has defined sarcopenia as a significant reduced mass and function of skeletal muscle with physical limitations due to aging. Clinically and experimentally, the foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Apparently, previous literature has shown that the intrinsic and extrinsic foot muscles have significantly reduced muscle morphology and muscle strength in the elderly compared to that of young healthy controls. How to effectively increase foot muscles using muscle-strengthening exercises will be a crucial issue for further research and clinical intervention in this population.
The intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g., the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program. Physiologically, the effects of integrated exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activate this kind of exercise efficiently and effectively is a key issue for employing these exercise interventions in the elderly with and without sarcopenia.
In this project, we will aim to employ the novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology in intrinsic and extrinsic foot muscles and foot posture before and after exercise intervention using sonographic imaging and foot posture index in the elderly with and without sarcopenia; second, we will investigate whether the immediate and persistent increase in balance control and level-walking after this therapeutic exercise with novel 3-D printing foot core exerciser.
Detailed description
In modern society with an increasing aging population, Asian Working Groups for Sarcopenia (AWSG) has defined sarcopenia as a significantly reduced mass and function of skeletal muscle with physical limitations due to aging. The prevalence in the globe has reported 5% - 25.7% of the elderly population and its associations are very high between daily activity limitations, physical limitations, and premature death. Clinically and experimentally, the foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Apparently, previous literature has shown that the intrinsic and extrinsic foot muscles have significantly reduced muscle morphology and muscle strength in the elderly compared to that of young healthy controls. How to effectively increase foot muscles using muscle-strengthening exercises will be a crucial issue for further research and clinical intervention in this population.
Anatomically, the intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g. the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program; Physiologically, the effects of integrated exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activate this kind of exercise efficiently and effectively is a key issue for employing these exercise interventions in the elderly with and without sarcopenia.
This project consists of two main parts - first, we will aim to employ the novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology in intrinsic and extrinsic foot muscles and foot posture before and after exercise intervention using sonographic imaging and foot posture index in the elderly with and without sarcopenia; second, we will investigate whether the immediate and persistent increase in balance control and level-walking after this therapeutic exercise with novel 3-D printing foot core exerciser. More importantly, we elucidate important clinical evidence-based information of long-term novel therapeutic exercise intervention for clinicians and health policymakers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Behavioral: integrated exercise therapy with 3D printing exerciser for training intrinsic foot musclesA novel-designed intrinsic foot muscle-strengthening exerciser using 3D printing techniques will be used in the experimental group. |
| Experimental group 2 | Sham comparator | Behavioral: regular exercises for the elderlyA regular exercise program will be provided in this group. |
| Control group | No intervention | –There is no exercise or other intervention in this group. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- the elderly with sarcopenia [1, 2] Age is more than 65 years with a medical diagnosis of sarcopenia Be able to independently stand and walk To meet the criteria of the definition of sarcopenia in the AWGS 2019 consensus update on sarcopenia diagnosis and treatment Be able to understand independently the participation consent in this research project
- Healthy elder individuals A neutral foot alignment: determined by measurement of the resting calcaneal stance position (RCSP: between 2˚of inversion and 2˚of eversion) and scores on the navicular drop (ND: between 5 and 9 mm) test.
- Foot Posture Index (FPI) Score is between 0 and 5. No pain in the lower limbs No history of lower limb injury that has affected function or caused the individual to seek previous medical or therapeutic intervention within 6 months
Key exclusion criteria (2 listed)
- All groups not be able to sign the consent form for the participation Traumatic injury to lower limbs which impacted joint integrity and function (i.e., fractures) resulting in at least 1 interrupted day of desired physical activity Major neurological, cardiorespiratory, or circulatory disorders contribute to not being able to independently stand and walk.
- Recent intervention/management within the last 6 months
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 |
|---|---|---|
| integrated exercise therapy with 3D printing exerciser for training intrinsic foot musclesAlso: novel foot core exercise programThe therapeutic exercise program with a custom-made 3-D printing foot core exerciser, consisting of warm-up exercise, active range of motion in the foot and ankle joints, foot core system strengthening program using the 3D printing device, and stretching exercises for foot and ankle. | Behavioural | Experimental group 1 |
| regular exercises for the elderlyAlso: regular exercisesThe regular exercise provided for the elderly in the dwelling community, including walking, simple aerobic exercises, stretching exercises | Behavioural | Experimental group 2 |
Primary outcome
Sonographic imaging for cross-sectional area of muscles
Time frame: changes among baseline, 4, 8 and 12 weeks
The diagnostic ultrasound will be employed to detect the cross-sectional area (CSA) in specific foot intrinsic and extrinsic muscles, such as extrinsic muscle (Flexor digitorum longus FDL, Flexor Hallucis Longus FHL, and Peroneal longus PL) and intrinsic muscle ( Abductor Hallucis AbdH, Flexor Digitorum Brevis FDB and Flexor Hallucis Brevis FHB) CSA. The unit is cm2
Sonographic imaging for the width and thickness of muscles
Time frame: changes among baseline, 4, 8 and 12 weeks
The diagnostic ultrasound will be employed to detect the width and thickness of specific foot intrinsic and extrinsic muscles, such as extrinsic muscles (FDL, FHL, and PER) and intrinsic muscle (AbdH, FDB, and FHB)width and thickness, and plantar fascia thickness (at the heel, mid and forefoot sites). The unit is cm (the width and length)
Balance test for standing posture for area of sway trajectory in center of pressure (CoP) and center of mass (CoM)
Time frame: changes among baseline, 4, 8 and 12 weeks
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Balance test for standing posture for the velocity of sway trajectory in center of pressure (CoP) and center of mass (CoM)
Time frame: changes among baseline, 4, 8 and 12 weeks
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm/sec.
Balance test for standing posture for the length of sway trajectory in center of pressure (CoP)
Time frame: changes among baseline, 4, 8 and 12 weeks
A complete lower limb model will be established through commercial motion analysis software. Motion Analysis System with 12 optoelectronic cameras and two high-speed video cameras with two force plates will be used for further analysis in standing and level walking. Static postural control will be assessed in a quiet standing task on the two force plates to measure the variables of the center of pressure (CoP) and center of mass (CoM) at eyes-open and eyes-closed conditions. The unit is mm.
Functional walking test for spatio-temporal parameters
Time frame: changes among baseline, 4, 8 and 12 weeks
Spatio-temporal parameters will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is m/sec.
Functional walking test for joint kinematics in the lower limb
Time frame: changes among baseline, 4, 8 and 12 weeks
Joint kinematic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is degree.
Functional walking test for joint kinetics in the lower limb
Time frame: changes among baseline, 4, 8 and 12 weeks
Joint kinetic data will be calculated during level walking. The subject will be asked to walk at slow, self-paced, and fast walking using a metronome. The unit is Nm.
Clinical Questionnaires for assessment in physical capacity in the elderly
Time frame: changes among baseline, 4, 8 and 12 weeks
Short Physical Performance Battery (0-12) questionnaires will be employed in this study. The unit is a unit on a scale.
Clinical Questionnaires for assessment in functional capacity and falling condition in the elderly
Time frame: changes among baseline, 4, 8 and 12 weeks
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Falling questionnaire (0-10) will be employed in this study. The unit is a unit on a scale.
Clinical Questionnaires for assessment in functional capacity and strength condition in the elderly
Time frame: changes among baseline, 4, 8 and 12 weeks
Strength, Assisting with walking, Rising from a chair, Climbing stairs, and Calf circumference (0-20). The unit is a unit on a scale.
4 secondary outcomes
Clinical Questionnaires for assessment in cognitive capacity in the elderly
Time frame: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in nutritional status in the elderly
Time frame: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in frail status in the elderly
Time frame: changes among baseline, 4, 8 and 12 weeks
Clinical Questionnaires for assessment in frailty condition the elderly
Time frame: changes among baseline, 4, 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 32033882Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
- Background: PubMed 22503991Dufour AB, Hannan MT, Murabito JM, Kiel DP, McLean RR. Sarcopenia definitions considering body size and fat mass are associated with mobility limitations: the Framingham Study. J Gerontol A Biol Sci Med Sci. 2013 Feb;68(2):168-74. doi: 10.1093/gerona/gls109. Epub 2012 Apr 13.
- Derived from this study: PubMed 38714957Kao SL, Hsiao ML, Wang JH, Chen CS, Chen SY, Shiau YJ, Yang CH. Effects of integrated intrinsic foot muscle exercise with foot core training device on balance and body composition among community-dwelling adults aged 60 and above. BMC Geriatr. 2024 May 7;24(1):403. doi: 10.1186/s12877-024-04945-y.
- 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.
Chich-Haung R Yang, PhD principal investigator
College of Medicine, Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated exercise therapy with 3D printing exerciser for training intrinsic foot muscles and regular exercises for the elderly in people with Sarcopenia and Muscle Weakness, run by Buddhist Tzu Chi General 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 3 inclusion and 2 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 2 Mar 2023. 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. Some participants in this study may receive a placebo. 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 Chich-Haung R Yang, PhD (+886-3-856-5301 ext. 2496, r.chyang@gms.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographic imaging for cross-sectional area of muscles (time frame: changes among baseline, 4, 8 and 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750888, which also lists 3 linked publications.
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 2 Mar 2023.