UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055542 |
|---|---|
| Receipt number | R000063453 |
| Scientific Title | Effects of virtual reality guided seated reaching exercises in hip fractures |
| Date of disclosure of the study information | 2024/09/19 |
| Last modified on | 2025/03/21 15:22:32 |
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Basic information
Public title
Effects of virtual reality guided seated reaching exercises on gait, posture and postural control after hip fractures - a randomized controlled trial
Acronym
Effects of virtual reality guided seated reaching exercises on gait, posture and postural control after hip fractures - a randomized controlled trial
Scientific Title
Effects of virtual reality guided seated reaching exercises in hip fractures
Scientific Title:Acronym
Effects of virtual reality guided seated reaching exercises in hip fractures
Region
| Japan |
Condition
Condition
Hip Fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate whether virtual reality guided seated reaching exercises improve postural control and gait in hip fracture patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10 metre walk time
Evaluation period: Pre-intervention and 2 weeks post-intervention
Key secondary outcomes
Standing centre of gravity sway, spinal alignment in sitting position, lower limb muscle strength (hip abduction, knee extension), lower limb joint range of motion (hip flexion, knee extension, ankle dorsiflexion), trunk muscle cross-sectional area (multifidus, psoas major, erector spinae muscle), trunk muscle thickness (internal oblique, external oblique, transverse abdominal muscle), dynamic balance ability, and use of walking aids (No device, cane, walker)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The standard intervention involves virtual reality-guided seated reaching exercises for two weeks (five times a week), with 100 reaches per session.
Interventions/Control_2
The standard intervention involves seated reaching exercises for two weeks (five times a week), with 100 reaches per session.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Surgery after fracture of the hip fractures
Patient after surgery for more than 4 weeks.
The patient can stand without upper limb support.
The patient can gait more than 10 meters (no device, cane, walker).
Pain on gait is less than 3 on the Numerical Rating Scale.
Key exclusion criteria
Hemiplegia after stroke
Under 65 years old
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kawanishi |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive Medical Science Research Institute
Zip code
559-8611
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture
TEL
0666166911
kengo_kawanishi@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Kawanishi |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive Medical Science Research Institute
Zip code
559-8611
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture
TEL
0666166911
Homepage URL
kengo_kawanishi@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences
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
Morinomiya University of Medical Sciences
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture
Tel
0666166911
kengo_kawanishi@morinomiya-u.ac.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
| 2024 | Year | 09 | Month | 19 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063453
