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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033277
Receipt No. R000037938
Official scientific title of the study 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 2018/07/13

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Basic information
Official scientific title of the study 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
Title of the study (Brief 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
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 24

Research contact person
Name of lead principal investigator Hiroshi Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Address Sannomiya 820, Koshigaya, Saitama
TEL +81489734706
Email takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person Hiroshi Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Address Sannomiya 820, Koshigaya, Saitama
TEL +81489734706
Homepage URL
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 11 Day
Anticipated trial start date
2018 Year 07 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.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


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