UMIN-CTR Clinical Trial

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
Last 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
1st 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