UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036379 |
|---|---|
| Receipt number | 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 10:54:27 |
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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
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
y_kato0928@yahoo.co.jp
Sponsor or person
Institute
Nakazuyagi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041346
