UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049213 |
|---|---|
| Receipt number | R000055573 |
| Scientific Title | The Effect of Using an trunk orthosis with joints providing resistive force on Walking Ability in Diabetic Neuropathy Patients undergoing Hemodialysis Therapy |
| Date of disclosure of the study information | 2022/10/14 |
| Last modified on | 2025/10/30 23:47:31 |
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Basic information
Public title
The Effect of Using an trunk orthosis with joints providing resistive force on Walking Ability in Diabetic Neuropathy Patients undergoing Hemodialysis Therapy
Acronym
Effects of an trunk orthosis with joints providing resistive force on Gait in Diabetic Neuropathy Patients undergoing Hemodialysis Therapy
Scientific Title
The Effect of Using an trunk orthosis with joints providing resistive force on Walking Ability in Diabetic Neuropathy Patients undergoing Hemodialysis Therapy
Scientific Title:Acronym
Effects of an trunk orthosis with joints providing resistive force on Gait in Diabetic Neuropathy Patients undergoing Hemodialysis Therapy
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of the use of a Trunk Orthosis with joints providing resistive force with potency on gait.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
4-meter walking test
Timed up and go test
tired feeling(modified Borg Scale)
Key secondary outcomes
Angle of hip extension in Terminal stance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Trunk Orthosis with joints providing resistive force
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. who are admitted to the hospital for dialysis treatment and scheduled to be hospitalized for more than 3 weeks
2. Those who have a prescription for physiotherapy from a rehabilitation physician and are scheduled for intervention for at least 3 weeks.
3. Those who are able to walk more than 6 meters with or without the use of walking aids.
4. Able to understand the instructions
5. who do not meet the contraindications for Trunk Orthosis with joints providing resistive force
6. Patients who fall within the Trunk Orthosis with joints providing resistive force M size (height (about 153 cm to 180 cm) and pelvic girth size (about 70 cm to 105 cm)) that we have at our hospital.
7. 18 years of age or older
Key exclusion criteria
Persons who are unable to perform physiotherapy interventions in the rehabilitation room due to infection or other reasons.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kurita |
| Middle name | |
| Last name | Shinya |
Organization
Tokyo Metropolitan Hospital organization Tokyo Metropolitan Ohkubo Hospital
Division name
Department of Rehabilitation
Zip code
168488
Address
2-44-1 Kabukichou sinjyukuku Tokyo
TEL
0352858811
shinya_kurita@tmhp.jp
Public contact
Name of contact person
| 1st name | Kurita |
| Middle name | |
| Last name | Shinya |
Organization
Tokyo Metropolitan Hospital organization Tokyo Metropolitan Ohkubo Hospital
Division name
Department of Rehabilitation
Zip code
168488
Address
2-44-1 Kabukichou sinjyukuku Tokyo
TEL
0352858811
Homepage URL
shinya_kurita@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Hospital organization Tokyo Metropolitan Ohkubo Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Tokyo Metropolitan Hospital organization Tokyo Metropolitan Ohkubo Hospital
Address
2-44-1 Kabukichou sinjyukuku Tokyo
Tel
0352858811
shinya_kurita@tmhp.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
| 2022 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Nothing
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jatpt/3/1/3_47/_article/-char/ja/
Number of participants that the trial has enrolled
1
Results
During the intervention period with TSC, comfortable walking speed improved from 0.7m/s to 1.0m/s compared with the conventional practice period. The pre-post difference on the modified Borg scale decreased from 3.5 to 2.3. SPPB scores increased from 6 (pre-A) to 8 (post-A) to 10 (post-B). Visual analysis using the standard deviation band method indicated improvement.
Results date posted
| 2025 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male, 40s type 2, diabetes, CKD stage 5, maintenance hemodialysis (3/week, 20 years). Barthel Index 80, supervised cane gait. Comfortable gait speed 0.53 m/s, SPPB 6.
Participant flow
Assessed for eligibility: n=1
Enrolled: n=1
Allocation: Period A (control) Period B(with orthosis)
Follow-up: no dropout
Analysis: n=1 (full analysis set)
Adverse events
No
Outcome measures
Primary outcomes
Comfortable gait speed (m/s; 10-m walk, mean of 3 trials)
Modified Borg scale (pre-post difference)
Secondary outcomes
Timed Up and Go (TUG, s)
SPPB total score (0-12)
Hip extension angle in late stance (2D video analysis/joint angle)
Patient-reported outcome: fatigue VAS
Time points: Pre-A, Post-A, Post-B (all non-dialysis days, immediately after practice)
Safety: Adverse events (falls, pain aggravation, skin problems)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055573
