UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057489 |
|---|---|
| Receipt number | R000065691 |
| Scientific Title | Effect of modified sit-to-stand training on load asymmetry in patients with hip fracture |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/04/02 15:24:30 |
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Basic information
Public title
Effect of modified sit-to-stand training on load asymmetry in patients with hip fracture
Acronym
Effect of modified sit-to-stand training on load asymmetry in patients with hip fracture
Scientific Title
Effect of modified sit-to-stand training on load asymmetry in patients with hip fracture
Scientific Title:Acronym
Effect of modified sit-to-stand training on load asymmetry in patients with hip fracture
Region
| Japan |
Condition
Condition
hip fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether modified sit-to-stand training increases the amount of load on the affected limb during sit-to-stand and walking in patients with hip fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left and right lower limb load during sit-to-stand, left and right lower limb load and stance time during walking, lower limb muscle strength, balance function, and gait speed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The modified sit-to-stand group stood with the affected limb positioned 1/2 posterior to the unaffected limb, and stood from a seat height set at 140% of the participant's lower leg length. The number of sit-to-stand was set to 10 times per set, and the number of sets was defined as the number of sets the participant felt "a little tight" in terms of lower limb fatigue. The number of sets was reset every week, and the number of sets performed was recorded for each patient. The training period was 2 weeks, 7 days a week, and a total of 14 interventions were performed.
Interventions/Control_2
In the normal sit-to-stand group, the participants stood up from the same position of the affected limb and the unaffected limb, and stood from a seat height set at 140% of the participant's lower leg length. The number of sit-to-stand was set to 10 times per set, and the number of sets was defined as the number of sets the participant felt "a little tight" in terms of lower limb fatigue. The number of sets was reset every week, and the number of sets performed was recorded for each patient. The training period was 2 weeks, 7 days a week, and a total of 14 interventions were performed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In patients with hip fracture who could perform sit-to-stand without upper limb support from seat height of 130% of their lower leg length and walk with or without a cane.
Key exclusion criteria
Orthopedic, central nervous system, neuromuscular, and internal disability diseases that significantly affect sit-to-stnad and walking.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Noda |
Organization
Graduate School, Seijoh University
Division name
Department of Health Care Studies
Zip code
4768588
Address
2-172 Fukinodai, Toukai-City, Aichi 476-8588, Japan
TEL
0526016000
atsuk107@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ochi |
Organization
Graduate School, Seijoh University
Division name
Department of Health Care Studies
Zip code
4768588
Address
2-172 Fukinodai, Toukai-City, Aichi 476-8588, Japan
TEL
0526016000
Homepage URL
ochi@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seijoh University
Address
2-172 Fukinodai, Toukai-City, Aichi 476-8588, Japan
Tel
0526016000
atsuk107@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065691
