UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055827 |
|---|---|
| Receipt number | R000063513 |
| Scientific Title | Does tele-prehabilitation improve the physical activity following lumbar spinal stenosis surgery? |
| Date of disclosure of the study information | 2024/10/14 |
| Last modified on | 2024/10/14 12:19:45 |
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Basic information
Public title
Does tele-prehabilitation improve the physical activity following lumbar spinal stenosis surgery?
Acronym
tele-prehabilitation in lumbar spinal stenosis surgery
Scientific Title
Does tele-prehabilitation improve the physical activity following lumbar spinal stenosis surgery?
Scientific Title:Acronym
tele-prehabilitation in lumbar spinal stenosis surgery
Region
| Japan |
Condition
Condition
Surgery cases of lumbar spinal canal stenosis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a tele-prehabilitation system and examine its effect on improving the amount of physical activity after LSS surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity 1 month before surgery, 1 day before surgery, 1 month after surgery, 3 months after surgery, and 6 months after surgery
Key secondary outcomes
Rate of completion of Tele-Prehabilitation, does its use help improve the amount of physical activity? and Would you recommend it to others? on a scale of 0-10, the JOA Back Pain Evaluation Questionnaire (JOABPEQ), the Oswestry Disability Index (ODI), and the 6-minute walk distance (6MWD)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the month before surgery, a booklet explaining the details of spine surgery and pre- and post-surgery care and an activity tracker will be distributed, and instructions will be given on how to operate the activity tracker so that patients can self-monitor their activity level.
Interventions/Control_2
The tele-prehabilitation group undergoes tele-prehabilitation with an application on a mobile device from one month before surgery to three months after surgery. The physical therapist will promote the continuation of physical activity through twice-weekly communication by chat.In the month before surgery, a booklet explaining the details of spine surgery and pre- and post-surgery care and an activity tracker will be distributed, and instructions will be given on how to operate the activity tracker so that patients can self-monitor their activity level.
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
selection criteria
1. Age at the enrollment is between 60 and 80 years old.
2. Patients diagnosed with lumbar spinal canal stenosis due to degenerative stenosis, slipped or spondylolisthesis.
3. The patient has been diagnosed with lumbar spinal canal stenosis and surgery has been performed after conservative treatment such as medications and injections have been ineffective.
4. Patients who have undergone lumbar decompression surgery alone or decompression surgery and posterior fusion surgery.
Key exclusion criteria
Exclusion Criteria
1. Patients with difficulties in activities of daily living due to orthopedic diseases. (e.g., patients with difficulty in walking due to knee osteoarthritis)
2. Patients with nerve palsy with a manual muscle test of the periarticular muscles of the ankle joint of 2 or less.
3. Patients with previous surgery or lateral fusion (XLIF).
4. Patients who cannot understand the questions on the JOABPEQ or who are suspected to have dementia are excluded if the HDSR is measured and the score is less than 20.
5. Cases that are complicated with severe medical diseases such as cardiac disease, renal disease, etc., and require specialist management at the time of surgery. Cases with a history of central nervous system diseases such as polio syndrome, Parkinson's disease, or cerebral infarction.
6. Other subjects whom the principal researcher or physician in charge deems inappropriate for the safe conduct of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Takenaka |
Organization
Tokoha University
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
431-2102
Address
1230 Miyakoda-cho, Hamana-ku, Hamamatsu City
TEL
053-428-3697
htakenaka@hm.tokoha-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mizutani |
Organization
Tokoha University Hamamatsu Campus
Division name
Hamamatsu general affairs
Zip code
431-2102
Address
1230 Miyakoda-cho, Hamana-ku, Hamamatsu City
TEL
053-428-3511
Homepage URL
y-mizutani@hm.tokoha-u.ac.jp
Sponsor or person
Institute
Tokoha University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Tokoha University
Address
1230 Miyakoda-cho, Hamana-ku, Hamamatsu City
Tel
053-428-3511
y-mizutani@hm.tokoha-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
春日井整形あさひ病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063513
