UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033277 |
|---|---|
| Receipt number | R000037938 |
| Scientific Title | Do leg lowering and active strait leg raise (SLR) exercises result in difference in trunk-limb control in people with dysfunction during active SLR: randomised controlled trial |
| Date of disclosure of the study information | 2018/07/10 |
| Last modified on | 2021/05/17 10:15:52 |
* 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
Do leg lowering and active strait leg raise (SLR) exercises result in difference in trunk-limb control in people with dysfunction during active SLR: randomised controlled trial
Acronym
Do leg lowering and active strait leg raise (SLR) exercises result in difference in trunk-limb control in people with dysfunction during active SLR: randomised controlled trial
Scientific Title
Do leg lowering and active strait leg raise (SLR) exercises result in difference in trunk-limb control in people with dysfunction during active SLR: randomised controlled trial
Scientific Title:Acronym
Do leg lowering and active strait leg raise (SLR) exercises result in difference in trunk-limb control in people with dysfunction during active SLR: randomised controlled trial
Region
| Japan |
Condition
Condition
Dysfunction in active SLR
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how leg lowering exercise and active SLR exercise influence on trunk-limb control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset and amplitude of surface EMG at trunk and lower limb muscles, joint position sense at the hip during active SLR, and 2-point discrimination test prior to exercise regime (T0), one month after the exercise regime (T1) and at one month after T1 when the exercise regime has been stopped.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Leg lowering exercise at home with 10 repetitions in each side with 3 sets per day for 4 weeks
Interventions/Control_2
Active SLR exercise at home with 10 repetitions in each side with 3 sets per day for 4 weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Finger touches the floor in forward flexion in standing.
Neither pain over the spine nor lower limb during the last 1 month.
No history of surgery in the back or hip.
Neither history of diagnosed disorders in the central nervous system nor history of diagnosed scoliosis.
Key exclusion criteria
Score 2 or 3 in Active SLR test in the Functional Movement Screening test.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
3438540
Address
Koshigaya
TEL
+81489734706
physical.therapy.takasaki@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
343-8540
Address
Sannomiya 820, Koshigaya, Saitama
TEL
+81489734706
Homepage URL
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefectural University
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
Saitama Prefectural University
Address
Sannomiya 820, Koshigaya, Saitama
Tel
+81489710500
rinri@spu.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
| 2018 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7939983/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7939983/
Number of participants that the trial has enrolled
40
Results
Forty participants were randomized to the ASLR exercise group (n=20) or the reverse-ASLR exercise group (n=20). The Fisher exact test demonstrated a statistically significant difference (P=0.020) in the proportion of those with FMS ASLR score improvement to a score of 2 (ASLR exercise group, one; reverse-ASLR exercise group, eight) at follow-up 1, but no significance (P=0.106) at follow-up 2 (ASLR exercise group, none; reverse-ASLR exercise group, four).
Results date posted
| 2021 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria were (a) age of >17 years, (b) no pain in the spine or lower extremities during the previous month, (c) no history of diagnosed spinal deformities or central nervous system disorders, and (d) ASLR-1-SMCD on both sides of ASLR.
Participant flow
Forty participants were randomized to the ASLR exercise group (n=20) or the reverse-ASLR exercise group (n=20).
Adverse events
None
Outcome measures
Relative latency of the onsets of the left rectus abdominis muscle, bilateral internal oblique muscles, bilateral external oblique muscles, left gluteus maximum muscle, and left hamstring muscles to the onset of the right rectus femoris muscle during the right ASLR and amplitude of activity in the left rectus abdominis muscle, bilateral internal oblique muscles, bilateral external oblique muscles, left gluteus maximum muscle, and left hamstring muscles at an early phase of the ASLR
The 2-point discrimination test
Joint repositioning acuity
The Japanese version of Euro QoL 5 Dimensions
Time for reaching to 95% of the hip flexion range
Data of demographics including age, sex, and body mass index
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 01 | 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
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
