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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036379
Receipt No. R000041346
Scientific Title Randomized controlled trial with parallel design on the effects of maximum voluntary velocity training in patients after femoral neck fracture surgery
Date of disclosure of the study information 2019/04/02
Last modified on 2019/04/02

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Basic information
Public title Randomized controlled trial with parallel design on the effects of maximum voluntary velocity training in patients after femoral neck fracture surgery
Acronym RCT on the effects of maximum voluntary velocity training after femoral neck fracture surgery
Scientific Title Randomized controlled trial with parallel design on the effects of maximum voluntary velocity training in patients after femoral neck fracture surgery
Scientific Title:Acronym RCT on the effects of maximum voluntary velocity training after femoral neck fracture surgery
Region
Japan

Condition
Condition femoral neck fracture
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of maximum voluntary velocity training, to improve knee extension maximum angular velocity of fracture side in patients following femoral neck fracture surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes knee extension maximum angular velocity of fracture side
Key secondary outcomes knee extension strength
30-sec Chair stand test (CS-30)
Timed up and go test (TUG)
10m maximum walking speed
new mobility score (NMS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 "Patients perform an evidence-based standardized rehabilitation program soon after surgery. They add high velocity knee extension and hip abduction exercises 2weeks after surgery.
The intervention will involve in hospital (6weeks on average, at most 10 weeks)."
Interventions/Control_2 "Patients perform an evidence-based standardized rehabilitation program soon after surgery. They add low velocity knee extension and hip abduction exercises 2weeks after surgery.
The intervention will involve in hospital (6weeks on average, at most 10 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with femoral neck or trochanteric fracture treated surgically, the patients reside in home with an independent pre-fracture ability to walk indoor, New Mobility Score (NMS) of 2 or more.
Key exclusion criteria Patients has a severe cognitive impairment.
Patients has a neurological disease.
pathological fracture.
Patients with reduced general condition or complications from the fracture resulting in delayed healing and associated weight-bearing restrictions.
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Yuuki
Middle name
Last name Shimada
Organization Nakazuyagi Hospital
Division name Department of Rehabilitation
Zip code 7700856
Address 1-31, nakazu-chou, tokushima-city, Tokushima, Japan
TEL 088-625-3535
Email y_kato0928@yahoo.co.jp

Public contact
Name of contact person
1st name Yuuki
Middle name
Last name Shimada
Organization Nakazuyagi Hospital
Division name Department of Rehabilitation
Zip code 7700856
Address 1-31, nakazu-chou, tokushima-city, Tokushima, Japan
TEL 088-625-3535
Homepage URL
Email y_kato0928@yahoo.co.jp

Sponsor
Institute Nakazuyagi Hospital
Institute
Department

Funding Source
Organization Nakazuyagi Hospital
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 Nakazuyagi Hospital
Address 1-31, nakazu-chou, tokushima-city, Tokushima, Japan
Tel 088-625-3535
Email y_kato0928@yahoo.co.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 中洲八木病院 (徳島県)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 02 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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 20 Day
Date of IRB
2018 Year 01 Month 19 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2020 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
2019 Year 04 Month 02 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041346

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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