UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032025 |
|---|---|
| Receipt number | R000036544 |
| Scientific Title | Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2024/03/14 15:43:32 |
* 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
Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Acronym
Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Scientific Title
Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Scientific Title:Acronym
Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to test whether the recovery of upper limb function in stroke patients would be enhanced by additionally carrying training aimed at improving sensory function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brunnstrom stage
Handgrip strength
Tactile-pressure threshold
Simple test for evaluating hand function (STEF)
Key secondary outcomes
Changes in handgrip strength, tactile pressure threshold, and STEF
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group
<Rehabilitation program>
1.ROM (Range of motion) training
2.facilitation (voluntary promotion training)
3.Muscle-strengthening exercise
4.Mobility skill exercises such as transferring, sitting up and Walking exercises
5.Standard of Exercises for ADL
6.Higher brain dysfunction training
<Sensory training program>
Several types of discrimination task performed under blind condition.
1.Three types of sandpaper, cloth (fur, satin fabric, linen cloth), 3 types of materials (0.5mm sponge cushioning materials, bubble wrap, flat plastic plate)
2.Braille plate
Interventions/Control_2
Control group
<Rehabilitation program>
1.ROM (Range of motion) training
2.facilitation (voluntary promotion training)
3.Muscle-strengthening exercise
4.Mobility skill exercises such as transferring, sitting up and Walking exercises
5.Standard of Exercises for ADL
6.Higher brain dysfunction training
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medically stable
Had no peripheral neuropathy or history of other neurological conditions
Had adequate comprehension of instructions and perceptual ability for testing
All were assessed to be free of unilateral neglect using clinical observation and standard neuropsychological assessment (shape cancellation and line bisection)
The Mini-Mental State Examination, which all of them passed (border line passing score of 24)
Key exclusion criteria
Any participants that does not meet the conditions specified in the above shall be null and void
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Murata |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL
095-819-7923
jmura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Murata |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL
095-819-7923
Homepage URL
jmura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7923
jmura@nagasaki-u.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
国立病院機構長崎医療センター/National Hospital Organization
Nagasaki Medical center
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1155/2019/6508261
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1155/2019/6508261
Number of participants that the trial has enrolled
56
Results
The mean change in the tactile pressure threshold was significantly larger in the experimental group than in the control group (p<0.05, d=0.59). Moreover, the completion times to manipulate a middle-sized ball (d=0.53) and small ball (d=0.80) and a small metal disc (d=0.81) in the experimental group were significantly different from those in the control group (p<0.05).
Results date posted
| 2024 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were hospitalized and receiving therapeutic interventions at the rehabilitation unit. The following inclusion criteria were used:first time stroke; the Revised Hasegawa Dementia Scale (HDS-R) score higher than 21; no severe cognitive deficits that preclude clinical evaluations, such as aphasia and unilateral neglect; and no other serious medical conditions.
Participant flow
A quasi-randomized 2-group pretest-posttest was used to examine the effects of the sensory training program in addition to standard rehabilitation therapy on paralyzed upper limbs. During the research period between July 2015 and January 2016, thirty-one subjects participated in the experimental group that performed the sensory training program in addition to standard rehabilitation therapy. After the end of this research period, an additional 25 patients were enrolled during the research period between February 2016 and August 2017 as the control group that received standard rehabilitation therapy without the sensory training program.
Adverse events
none
Outcome measures
The mean change in the tactile pressure threshold was significantly larger in the experimental group than in the control group (p<0.05, d=0.59). Moreover, the completion times to manipulate a middle-sized ball (d=0.53) and small ball (d=0.80) and a small metal disc (d=0.81) in the experimental group were significantly different from those in the control group (p<0.05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 04 | 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 | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036544
