UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051101 |
|---|---|
| Receipt number | R000058236 |
| Scientific Title | Immediate Effect of Training for Quick Lateral Movement of the Trunk with Sling Exercise on Balance and Walking Ability in Elderly People : A Focus on the Level of Spinal Kyphosis |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2026/04/22 00:05:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Immediate Effect of Training for Quick Lateral Movement of the Trunk with Sling Exercise on Balance and Walking Ability in Elderly People
Acronym
Immediate Effect of Training for Quick Lateral Movement of the Trunk with Sling Exercise on Balance and Walking Ability in Elderly People
Scientific Title
Immediate Effect of Training for Quick Lateral Movement of the Trunk with Sling Exercise on Balance and Walking Ability in Elderly People : A Focus on the Level of Spinal Kyphosis
Scientific Title:Acronym
Immediate Effect of Training for Quick Lateral Movement of the Trunk with Sling Exercise on Balance and Walking Ability in Elderly People : A Focus on the Level of Spinal Kyphosis
Region
| Japan |
Condition
Condition
kyphosis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify immediate effect of training for quick lateral movement of the trunk with the lumber sling on balance and walking ability in elderly people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gait velocity
Key secondary outcomes
Timed Up & Go Test,One Leg Standing,Functional Reach,Sit-and-Reach Distance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
training for quick lateral movement of the trunk with sling exercise
Interventions/Control_2
training for quick lateral movement of the trunk
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
Include criteria are as follows : a person who be aged 65 or over, and who be able to stand independently without upper extremities, and who be able to walk independently with a cane or no aid.
Key exclusion criteria
Exclusion criteria are as follows: those who have experienced stroke and have paralyzed upper or lower extremities Brumstorm stage one to five, those who have diagnosed intractable neurological diseases ,those who had a surgical operation of spine in the past,those who have diagnosed spinal disease and have motor paralysis, those who have experienced compression fracture within 6monthes of the study,those who have pain that limit movement, prominent visual disturbance ,vestibular impairment,those who can not understand the experiment.
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Yamada(Takita) |
Organization
Leben community corporation
Division name
Yanagishima Rehabilitation Center My Reha division
Zip code
3400033
Address
1,Yanagishima Souka City Saitama
TEL
0489211500
yamada.m@myreha.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Yamada |
Organization
Leben community corporation
Division name
Yanagishima Rehabilitation Center My Reha division
Zip code
3400033
Address
1,Yanagishima Souka City Saitama
TEL
0489211500
Homepage URL
yamada.m@myreha.jp
Sponsor or person
Institute
Yanagishima Rehabilitation Center My Reha division Leben community corporation
Institute
Department
Personal name
Funding Source
Organization
none
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
Japanese Society Of Physical Therapy
Address
7-11-10 Roppongi, Minato-ku, Tokyo 106-0032, JAPAN
Tel
03-6721-0603
ethics@japanpt.or.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
| 2023 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
https://doi.org/10.14901/ptkanbloc.43.0_151_151
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.14901/ptkanbloc.43.0_151_151
Number of participants that the trial has enrolled
40
Results
In the unweighting group, walking speed, the Functional Reach Test, and the sit-and-reach test improved significantly between pre- and post-intervention, while the number of steps decreased significantly. In the non-unloading group, walking speed and the Functional Reach Test improved significantly, while step count and the Timed Up and Go test decreased significantly.
Results date posted
| 2026 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As basic information of the subjects, age, gender, medical history, surgical history, history of falls, level of care, and modes of mobility were investigated. There were no significant differences in background between the two groups.
Participant flow
A total of 53 participants were enrolled, but 2 were excluded due to illness. The remaining 51 participants were randomized using a block randomization method into a non-weight-bearing group (25 participants) and a weight-bearing group (26 participants), and analyses were conducted for each group following the intervention.
Adverse events
During the study period, no adverse events occurred in the subjects.
Outcome measures
In both groups, the 8-meter maximum walking speed (hereinafter, 8mMax), Timed Up & Go Test (hereinafter, TUG), one-leg standing test with eyes open (hereinafter, OLS), Functional Reach Test (hereinafter, FRT), and seated forward bend were measured before and after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058236
