StabilityNCT05663229
Postural Analysis of Patients Receiving Rehabilitation Program
An observational study of Stability, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a study for evaluation of posture of patients with neurological disease in rehabilitation department. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stability
- What is being tested?
- Ankle foot orthosis
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 28 Jul 2023
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with physical disability followed-up in rehabilitation department
Who may be able to join
- Patient with physical disability followed-up in rehabilitation department
Who cannot join
- Patients with congitive impairment that can't complete the evalaution well
- Patients with uncontrolled comorbidity diseases
- Attended other study in recent 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
aohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
About this study
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital
This is a study for evaluation of posture of patients with neurological disease in rehabilitation department.
Read the detailed description
In this study, we evaluate the static posture stability of the patient, such as during sitting, standing and dynamic posture stability of the patient, such as during walking, time-up-and-go test.
- Conditions
- Stability
- Being tested
- Ankle foot orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle foot orthosisDevice
We evaluate the difference of with or without ankle foot orthosis
| Study group | Role | What they receive |
|---|---|---|
| Experimental group-with rehabilitation intervention | We evaluate the static or dynamic posture stability of patients with rehabilitation intervention Receives: Device: Ankle foot orthosis | |
| Control group-without rehabilitation intervention | We evaluate the static or dynamic posture stability of patients without rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of center of gravity during standing
Data collected by motion analysis system
Measured: 1 day
Displacement of center of gravity during walking
Data collected by motion analysis system
Measured: 1 day
Secondary outcomes (6)
Trunk movement
Data collected by motion analysis system
Measured: 1 day
Hip movement
Data collected by motion analysis system
Measured: 1 day
Knee movement
Data collected by motion analysis system
Measured: 1 day
Ankle movement
Data collected by motion analysis system
Measured: 1 day
Foot pressure
Data collected by Pedar (foot pressure system)
Measured: 1 day
Foot reaction force
Data collected by Pedar (foot pressure system) and force plate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Dec 2022
- Primary completion15 Dec 2022
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StabilityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Hsuan Tseng, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663229
- Sponsor's protocol ID
- KMUHIRB-E(II)-20220039
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2022
- Last updated
- 23 Oct 2023
- Results posted
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- ClinicalTrials.gov ID
- NCT05663229
- Acronym / sponsor ID
- KMUHIRB-E(II)-20220039
- Conditions
- Stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 23 Dec 2022 (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 is a study for evaluation of posture of patients with neurological disease in rehabilitation department.
Detailed description
In this study, we evaluate the static posture stability of the patient, such as during sitting, standing and dynamic posture stability of the patient, such as during walking, time-up-and-go test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group-with rehabilitation intervention | – | Device: Ankle foot orthosisWe evaluate the static or dynamic posture stability of patients with rehabilitation intervention |
| Control group-without rehabilitation intervention | – | –We evaluate the static or dynamic posture stability of patients without rehabilitation intervention |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with physical disability followed-up in rehabilitation department
Key inclusion criteria (1 listed)
- Patient with physical disability followed-up in rehabilitation department
Key exclusion criteria (3 listed)
- Patients with congitive impairment that can't complete the evalaution well
- Patients with uncontrolled comorbidity diseases
- Attended other study in recent 3 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 |
|---|---|---|
| Ankle foot orthosisWe evaluate the difference of with or without ankle foot orthosis | Device | Experimental group-with rehabilitation intervention |
Primary outcome
Displacement of center of gravity during standing
Time frame: 1 day
Data collected by motion analysis system
Displacement of center of gravity during walking
Time frame: 1 day
Data collected by motion analysis system
6 secondary outcomes
Trunk movement
Time frame: 1 day
Hip movement
Time frame: 1 day
Knee movement
Time frame: 1 day
Ankle movement
Time frame: 1 day
Foot pressure
Time frame: 1 day
Foot reaction force
Time frame: 1 day
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 23 Oct 2023.
- 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.
Yu Hsuan Tseng principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stability, run by Kaohsiung Medical University Chung-Ho Memorial 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 1 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: finished, as of the sponsor's last update on 23 Oct 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. 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?
Displacement of center of gravity during standing (time frame: 1 day). 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 23 Oct 2023.