Sarcopenia in ElderlyNCT07197528
Effectiveness of Smart-Assisted Rehabilitation Exercise Training on the Physical and Mental Health of Older Adults in Long-Term Care Facilities
A study of Sarcopenia in Elderly and Rehabilitation Exercise, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness of a smart-assisted rehabilitation system on the physical and mental health of elderly residents in long-term care facilities through exercise training. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Rehabilitation Exercise, Long Term Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2025to 18 May 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
- Adults aged 65 years or older residing in long-term care facilities and diagnosed with sarcopenia, defined as:
- Handgrip strength: <28 kg for males or <18 kg for females, or
- Calf circumference (10 cm below the knee): <34 cm for males or <33 cm for females.
- Able to stand with assistive devices (e.g., walker), transfer from bed to chair using a wheelchair, or ambulate independently.
- Clear consciousness, able to communicate, and able to provide informed consent.
- Willing to participate and comply with the exercise intervention.
Who cannot join
- Impaired consciousness.
- Unsuitable for wearing the device due to any leg-related medical condition.
- Unable to perform aerobic or resistance training due to neurological or musculoskeletal disorders.
- History of head injury resulting in cognitive impairments such as memory or attention deficits.
- Assessed by a rehabilitation specialist as having absolute or relative contraindications to exercise training, such as:
- Severe myocardial ischemia
Show all 14Show fewer
- Myocardial infarction within the past 6 months
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic instability
- Severe aortic valve stenosis
- Deemed unsuitable to participate in the study by a rehabilitation specialist due to conditions such as end-stage renal disease requiring dialysis, terminal cancer, or ongoing chemotherapy/radiation therapy.
- Diagnosed with depression or experienced major life events in the past six months.
- Fracture, sports injury of the limbs, stroke, dementia, or other major illness within the past six months.
- Individuals with infectious disease risks.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Banqiao Veterans Home of Veterans Affairs Council, R.O.C.
New Taipei City, Banqiao Dist, 220250
About this study
Official title: Effectiveness of Precision Rehabilitative Exercise Training on Sarcopenia, Joint Range of Motion, Cognitive Function, Activities of Daily Living, Quality of Life, and Mood Status in Elderly Residents of Long-Term Care Facilities
The purpose of this clinical trial is to evaluate the effectiveness of a smart-assisted rehabilitation system on the physical and mental health of elderly residents in long-term care facilities through exercise training.
The specific aim of this study is to investigate the effects of a 12-week exercise training program using a smart-assisted rehabilitation system on sarcopenia, joint range of motion, cognitive function, activities of daily living, functional status, quality of life, and emotional well-being among institutionalized older adults.
Read more
Participants will be divided into an experimental group and a control group for comparison to assess whether the intervention improves outcomes such as sarcopenia, joint mobility, cognitive function, daily living abilities, overall functional status, quality of life, and emotional state.
Participants in the experimental group will receive the "KNEESUP" smart medical rehabilitation system, provided by a co-investigator. A rehabilitation physician will design an individualized, progressive exercise program. The intervention is planned for 12 weeks, with a frequency of 3 days per week, 2 sessions per day, totaling 72 sessions.
Read the detailed description
This clinical trial aims to evaluate the effectiveness of a 12-week exercise intervention using an intelligent rehabilitation assistance system (KNEESUP) in improving the physical and mental health of institutionalized older adults with sarcopenia in long-term care facilities.
With the rapid aging of the population, long-term care institutions have become crucial in supporting the quality of life for older adults. Residents in these settings often face compounded challenges, including chronic illnesses, reduced physical function, cognitive decline, and psychosocial issues such as loneliness and depression. These conditions increase the burden on healthcare systems and care staff. While exercise interventions are known to be effective in promoting physical and mental well-being in older adults, traditional standardized programs may lack individualization and precision.
This study introduces a smart rehabilitation system that combines wearable technology and personalized exercise prescriptions designed by a physical medicine and rehabilitation physician. The system allows real-time monitoring and feedback, which enhances safety, motivation, and adherence. The intervention aligns with trends in post-pandemic digital health solutions and aims to integrate medical technology into routine elder care.
Study Design A randomized controlled trial will be conducted. Eligible participants (aged ≥65 with sarcopenia, able to stand with assistance or walk with/without aid, and cognitively intact) will be randomly assigned to either an intervention or control group in a 1:1 ratio. The sample size was calculated using G*Power, estimating 42 participants to account for a 20% dropout rate.
Intervention group: Receives a 12-week progressive resistance training program using the KNEESUP smart rehabilitation system. Training will occur 3 times per week, twice per day, totaling 72 sessions. Exercises include lower-limb strengthening through progressive stages (bed, seated, and standing), designed by a team of multidisciplinary experts and monitored via wearable sensors.
Control group: Continues routine care and usual physical activity without additional intervention.
Outcome Measures
Participants will be assessed pre- and post-intervention on the following variables:
Sarcopenia indicators: Grip strength, limb circumference
Joint range of motion: Measured with goniometer (upper limbs) and the KNEESUP system (lower limbs)
Cognitive function: Short Portable Mental Status Questionnaire (SPMSQ)
Daily living function: Barthel Index
Functional status: Comprehensive Geriatric Assessment (CGA)
Quality of life: WHOQOL-BREF (Taiwan version)
Emotional state: Geriatric Depression Scale (GDS-15)
Basic demographic and lifestyle data: Age, sex, education, comorbidities, social support, and physical activity habits
Statistical Analysis Data will be analyzed using SPSS. Descriptive statistics (mean, SD, percentage) and inferential statistics (independent t-tests, chi-square tests, ANOVA, and generalized estimating equations [GEE]) will be used to assess within-group and between-group differences, and group × time interaction effects. Significance is set at α = 0.05.
Data Management and Confidentiality All data will be anonymized. Paper and electronic data will be securely stored and encrypted. Data will be destroyed 5 years after study completion. Only authorized personnel will have access.
Ethical Considerations The study has IRB approval and informed consent will be obtained from all participants or their legal guardians. Risks (e.g., muscle soreness or fatigue) will be mitigated with one-on-one supervision. Emergency procedures and referral systems are in place if adverse events occur.
Expected Impact This study is expected to provide evidence supporting the feasibility and effectiveness of smart rehabilitation systems in long-term care. It may serve as a model for future eldercare strategies, inform policy, and contribute to the development of precision geriatric rehabilitation approaches.
- Being tested
- Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activity
- Keywords
- sarcopenia, elderly, rehabilitation, Long Term Care
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activityBehavioural
Interventions
Behavioral: Smart-assisted rehabilitation exercise system ("KNEESUP") A wearable smart-assisted rehabilitation system providing personalized, progressive lower limb resistance training for elderly residents with sarcopenia in long-term care institutions. The system includes real-time monitoring, feedback, and remote adjustment by rehabilitation specialists. Unlike traditional programs, it integrates sensor technology to track knee joint angles and exercise performance, enabling precise and adaptive training.
Other: Usual care / routine physical activity Participants follow standard daily activities and rehabilitation provided by the long-term care facility, without the smart-assisted rehabilitation system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Experimental: Intervention Group Participants will receive a 12-week exercise training program using the smart-assisted rehabilitation system "KNEESUP." The training includes progressive resistance exercises tailored to individual functional abilities, conducted three times per week with two sessions per day. The system provides real-time monitoring, feedback, and remote adjustments by rehabilitation specialists. Receives: Behavioral: Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activity |
| Control Group | No intervention | Participants will receive usual care, including standard daily activities and routine rehabilitation therapies provided by the long-term care facility, without use of the smart-assisted rehabilitation system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb grip strength
Grip strength was assessed using the Jamar 5030J1 analog dynamometer. Participants performed two consecutive grip tests with their dominant hand, and the highest value from the two trials was recorded. Grip strength values indicating possible sarcopenia are <28 kg for males and <18 kg for females.
Measured: From enrollment to the end of treatment at 12 weeks
Calf and arm circumferences
Calf and arm circumferences will be measured using a tape measure.
Calf circumference: measured in a seated position at the widest part of the calf. A value <34 cm for males and <33 cm for females indicates risk of sarcopenia.
Arm circumference: measured at the midpoint of the non-dominant upper arm. A value ≤28.6 cm for males and ≤27.5 cm for females indicates risk of sarcopenia.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Range of Motion
For the upper limbs, joint angles of the shoulder and elbow were measured using a traditional goniometer. For the lower limbs, the hip and knee joints were measured using the "KNEESUP" device and its associated application. After turning on the "KNEESUP" device, it connects to a smartphone via Bluetooth, allowing the sensor to detect the participant's lower limb movements, knee flexion angles, the time taken to complete movements, and the accuracy of the movements. These data are transmitted to the app for analysis.
Measured: From enrollment to the end of treatment at 12 weeks
Cognitive Function
This study uses the Short Portable Mental Status Questionnaire (SPMSQ) to assess the cognitive function of elderly participants. The questionnaire covers six dimensions: consciousness, memory, orientation, attention, thinking, and general knowledge, with a total of 10 items.
Measured: From enrollment to the end of treatment at 12 weeks.
Activities of Daily Living (ADL)
This study uses the Barthel Index to assess the basic self-care abilities of elderly individuals in the community and all care facilities. The main assessment items include seven self-care abilities and three mobility skills, totaling 10 evaluation items. The scores are categorized as follows: complete dependence (0-20 points), severe dependence (21-60 points), moderate dependence (61-90 points), mild dependence (91-99 points), and complete independence (100 points).
Measured: From enrollment to the end of treatment at 12 weeks.
Quality of Life Assessed Using WHOQOL-BREF
The Taiwan version of the WHOQOL-BREF consists of 28 items, including two global items assessing overall quality of life and general health, and 26 items across four domains: physical health, psychological health, social relationships, and environment. Each item uses a 5-point Likert scale. Negatively phrased items are reverse-coded. Higher scores reflect better perceived quality of life. This version includes two additional culturally relevant items developed for the Taiwanese population. Domain reliability ranges from Cronbach's α = 0.70 to 0.77.
Measured: From enrollment to the end of treatment at 12 weeks.
Depressive Symptoms Assessed Using the Chinese Version of the Geriatric Depression Scale-15 (CT-GDS-15)
Emotional status will be assessed using the Chinese-Translated Geriatric Depression Scale-15 (CT-GDS-15), a 15-item screening tool for depressive symptoms in older adults. Items are answered with "yes" or "no" and scored 0-15. Higher scores indicate more severe depressive symptoms. A score of 0-6 suggests normal emotional status, 7-10 indicates mild to moderate depression, and ≥11 suggests severe depression requiring further evaluation. The scale has a reported sensitivity of 72% and specificity of 57% based on DSM-III criteria.
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start17 Feb 2025
- Primary completion18 May 2025
- Study completion18 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZENG SIOU RONG, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197528
- Sponsor's protocol ID
- A202405161
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2025
- Last updated
- 29 Sep 2025
- 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Precision Rehabilitative Exercise Training on Sarcopenia, Joint Range of Motion, Cognitive Function, Activities of Daily Living, Quality of Life, and Mood Status in Elderly Residents of Long-Term Care Facilities
- ClinicalTrials.gov ID
- NCT07197528
- Acronym / sponsor ID
- A202405161
- Keywords
- sarcopenia, elderly, rehabilitation, Long Term Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 18 May 2025 (actual)
- Study completion
- 18 May 2025 (actual)
- First posted
- 29 Sep 2025 (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.
The purpose of this clinical trial is to evaluate the effectiveness of a smart-assisted rehabilitation system on the physical and mental health of elderly residents in long-term care facilities through exercise training.
The specific aim of this study is to investigate the effects of a 12-week exercise training program using a smart-assisted rehabilitation system on sarcopenia, joint range of motion, cognitive function, activities of daily living, functional status, quality of life, and emotional well-being among institutionalized older adults.
Participants will be divided into an experimental group and a control group for comparison to assess whether the intervention improves outcomes such as sarcopenia, joint mobility, cognitive function, daily living abilities, overall functional status, quality of life, and emotional state.
Participants in the experimental group will receive the "KNEESUP" smart medical rehabilitation system, provided by a co-investigator. A rehabilitation physician will design an individualized, progressive exercise program. The intervention is planned for 12 weeks, with a frequency of 3 days per week, 2 sessions per day, totaling 72 sessions.
Detailed description
This clinical trial aims to evaluate the effectiveness of a 12-week exercise intervention using an intelligent rehabilitation assistance system (KNEESUP) in improving the physical and mental health of institutionalized older adults with sarcopenia in long-term care facilities.
With the rapid aging of the population, long-term care institutions have become crucial in supporting the quality of life for older adults. Residents in these settings often face compounded challenges, including chronic illnesses, reduced physical function, cognitive decline, and psychosocial issues such as loneliness and depression. These conditions increase the burden on healthcare systems and care staff. While exercise interventions are known to be effective in promoting physical and mental well-being in older adults, traditional standardized programs may lack individualization and precision.
This study introduces a smart rehabilitation system that combines wearable technology and personalized exercise prescriptions designed by a physical medicine and rehabilitation physician. The system allows real-time monitoring and feedback, which enhances safety, motivation, and adherence. The intervention aligns with trends in post-pandemic digital health solutions and aims to integrate medical technology into routine elder care.
Study Design A randomized controlled trial will be conducted. Eligible participants (aged ≥65 with sarcopenia, able to stand with assistance or walk with/without aid, and cognitively intact) will be randomly assigned to either an intervention or control group in a 1:1 ratio. The sample size was calculated using G*Power, estimating 42 participants to account for a 20% dropout rate.
Intervention group: Receives a 12-week progressive resistance training program using the KNEESUP smart rehabilitation system. Training will occur 3 times per week, twice per day, totaling 72 sessions. Exercises include lower-limb strengthening through progressive stages (bed, seated, and standing), designed by a team of multidisciplinary experts and monitored via wearable sensors.
Control group: Continues routine care and usual physical activity without additional intervention.
Outcome Measures
Participants will be assessed pre- and post-intervention on the following variables:
Sarcopenia indicators: Grip strength, limb circumference
Joint range of motion: Measured with goniometer (upper limbs) and the KNEESUP system (lower limbs)
Cognitive function: Short Portable Mental Status Questionnaire (SPMSQ)
Daily living function: Barthel Index
Functional status: Comprehensive Geriatric Assessment (CGA)
Quality of life: WHOQOL-BREF (Taiwan version)
Emotional state: Geriatric Depression Scale (GDS-15)
Basic demographic and lifestyle data: Age, sex, education, comorbidities, social support, and physical activity habits
Statistical Analysis Data will be analyzed using SPSS. Descriptive statistics (mean, SD, percentage) and inferential statistics (independent t-tests, chi-square tests, ANOVA, and generalized estimating equations [GEE]) will be used to assess within-group and between-group differences, and group × time interaction effects. Significance is set at α = 0.05.
Data Management and Confidentiality All data will be anonymized. Paper and electronic data will be securely stored and encrypted. Data will be destroyed 5 years after study completion. Only authorized personnel will have access.
Ethical Considerations The study has IRB approval and informed consent will be obtained from all participants or their legal guardians. Risks (e.g., muscle soreness or fatigue) will be mitigated with one-on-one supervision. Emergency procedures and referral systems are in place if adverse events occur.
Expected Impact This study is expected to provide evidence supporting the feasibility and effectiveness of smart rehabilitation systems in long-term care. It may serve as a model for future eldercare strategies, inform policy, and contribute to the development of precision geriatric rehabilitation approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activityExperimental: Intervention Group Participants will receive a 12-week exercise training program using the smart-assisted rehabilitation system "KNEESUP." The training includes progressive resistance exercises tailored to individual functional abilities, conducted three times per week with two sessions per day. The system provides real-time monitoring, feedback, and remote adjustments by rehabilitation specialists. |
| Control Group | No intervention | –Participants will receive usual care, including standard daily activities and routine rehabilitation therapies provided by the long-term care facility, without use of the smart-assisted rehabilitation system. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Adults aged 65 years or older residing in long-term care facilities and diagnosed with sarcopenia, defined as:
- Able to stand with assistive devices (e.g., walker), transfer from bed to chair using a wheelchair, or ambulate independently.
- Clear consciousness, able to communicate, and able to provide informed consent.
- Willing to participate and comply with the exercise intervention.
Key exclusion criteria (14 listed)
- Impaired consciousness.
- Unsuitable for wearing the device due to any leg-related medical condition.
- Unable to perform aerobic or resistance training due to neurological or musculoskeletal disorders.
- History of head injury resulting in cognitive impairments such as memory or attention deficits.
- Assessed by a rehabilitation specialist as having absolute or relative contraindications to exercise training, such as:
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 |
|---|---|---|
| Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activityInterventions Behavioral: Smart-assisted rehabilitation exercise system ("KNEESUP") A wearable smart-assisted rehabilitation system providing personalized, progressive lower limb resistance training for elderly residents with sarcopenia in long-term care institutions. The system includes real-time monitoring, feedback, and remote adjustment by rehabilitation specialists. Unlike traditional programs, it integrates sensor technology to track knee joint angles and exercise performance, enabling precise and adaptive training. Other: Usual care / routine physical activity Participants follow standard daily activities and rehabilitation provided by the long-term care facility, without the smart-assisted rehabilitation system. | Behavioural | Intervention Group |
Primary outcome
Upper limb grip strength
Time frame: From enrollment to the end of treatment at 12 weeks
Grip strength was assessed using the Jamar 5030J1 analog dynamometer. Participants performed two consecutive grip tests with their dominant hand, and the highest value from the two trials was recorded. Grip strength values indicating possible sarcopenia are <28 kg for males and <18 kg for females.
Calf and arm circumferences
Time frame: From enrollment to the end of treatment at 12 weeks
Calf and arm circumferences will be measured using a tape measure. Calf circumference: measured in a seated position at the widest part of the calf. A value <34 cm for males and <33 cm for females indicates risk of sarcopenia. Arm circumference: measured at the midpoint of the non-dominant upper arm. A value ≤28.6 cm for males and ≤27.5 cm for females indicates risk of sarcopenia.
5 secondary outcomes
Range of Motion
Time frame: From enrollment to the end of treatment at 12 weeks
Cognitive Function
Time frame: From enrollment to the end of treatment at 12 weeks.
Activities of Daily Living (ADL)
Time frame: From enrollment to the end of treatment at 12 weeks.
Quality of Life Assessed Using WHOQOL-BREF
Time frame: From enrollment to the end of treatment at 12 weeks.
Depressive Symptoms Assessed Using the Chinese Version of the Geriatric Depression Scale-15 (CT-GDS-15)
Time frame: From enrollment to the end of treatment at 12 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 29 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia in Elderly
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
RecruitingObservational study
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Colorectal Cancer, Sarcopenia
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
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 of Sarcopenia in Elderly and Rehabilitation Exercise, run by Tri-Service General Hospital (TSGH) 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 14 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 29 Sep 2025. 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?
Upper limb grip strength (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 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 29 Sep 2025.