UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022509 |
|---|---|
| Receipt number | R000025480 |
| Scientific Title | The efficacy of upper extremity robotic therapy combined with constraint-induced movement therapy in chronic post-stroke hemiplegia. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2022/04/20 15:08:25 |
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Basic information
Public title
The efficacy of upper extremity robotic therapy combined with constraint-induced movement therapy in chronic post-stroke hemiplegia.
Acronym
ReoGo-J study
Scientific Title
The efficacy of upper extremity robotic therapy combined with constraint-induced movement therapy in chronic post-stroke hemiplegia.
Scientific Title:Acronym
ReoGo-J study
Region
| Japan |
Condition
Condition
Post-stroke upper extremity hemiplegia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of robotic therapy alone or conbined with constraint-induced movement therapy on motor function and ADL in chronic post-stroke hemiplegiain patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in upper extremity Fugl-Meier acore
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
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Self training with robotic device + Usual care
Interventions/Control_2
Self training with robotic device + Constraint-induced movement therapy
Interventions/Control_3
Usual care
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients must be able to understand and willing to sign a written informed consent
2. Age >= 20 and <80
3. Patients who experienced clinically incipient stroke upon the cerebellar tentorium more than 6 months ago
Key exclusion criteria
1. Patients with clinically multiple stroke or stroke below the cerebellar tentorium
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL
0798-45-6111
domen@neuro-reha.org
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Uchiyama |
Organization
Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
0798-45-6111
Homepage URL
domen@neuro-reha.org
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Moji Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine Independent Ethics Committee
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fneur.2018.00730
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1161/STROKEAHA.121.037260
Number of participants that the trial has enrolled
129
Results
The change score of FMA upper limb items score as the primary outcome was not significantly different between three groups. In those,etc who completed over 80% of overall training time (PPS), when robotic therapy is used for self-training, patient's upper limb (shoulder, elbow, and forearm) functions are significantly improved compared to those who only received usual care for self-training.
Results date posted
| 2022 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 29 | Day |
Baseline Characteristics
The number of enrolled subjects was 129 patients. Participants were randomly allocated to three groups; robotic therapy with usual care group (44 cases), robotic therapy with task-oriented therapy group (43 cases), and usual care group (42 cases).
We showed the characteristics of participants in this study following: the average age in each group were 59 years (robotic therapy with usual care group), 60 years (robotic therapy with task-oriented therapy group), and 59 years (usual care group);
the gender in each group were 34 males and 10 females (robotic therapy with usual care group) , 35 males and 8 females (robotic therapy with task-oriented therapy group), and 31 males and 11 females (usual care group).
Consequently, there were no differences in the average of age and gender among the three groups.
Participant flow
The first subject was enrolled on 11/29/2016. There were only three cases at the end of 12/2016; therefore, the registration and implementation periods needed to be extended by a year to 3/31/2018 and 3/31/2019, respectively.
The questionnaire results and the efforts of each medical institution were shared in a study group in 6/2017.
Marketing channels, such as newspaper advertisements, website postings, posters, and fliers, were also taken into account for recruiting subjects at medical institutions whenever possible.
Nevertheless, as only 57 subjects were enrolled, in the end of 12/2017, the registration period has been extended for 6 months until 9/30/2018 at the end of 12/2017.
In addition, four medical institutions were added, although one of them abandoned the program.
By the end of 4/2018, 23 medical institutions were participating.
Thereafter with the enforcement of Clinical Trials Act, the transition procedure of this study to Specified Clinical Trial had started, and it was approved on 11/30/2018 by the Tsukuba University Clinical Research Review Board.
The number of cases registered was 111 at the end of 7/2018; however, the registration period was extended to 11/30/2018 for 2months to recruit more subjects to take into account possible dropouts and withdrawals.
The final number of registrations as of 11/12/2018 was 129, which was divided as follows: 13 cases each from two facilities, seven cases each from six facilities, six cases each from five facilities, and a total of 31 cases from the remaining 11 facilities (1-5 cases/facility).
Adverse events
In this study, no disease (including disability, death, or infection, as well as abnormal laboratory test values, or symptoms suspected to be caused by clinical study) was observed.
However, one case of cholelithiasis (hospitalization/ laparoscopic cholecystectomy / unrelated) was observed, in the robot with usual care group, and was reported as a serious adverse event.
In addition, no health damage was observed with respect to device malfunction, and there was no impact on the implementation of the test.
Outcome measures
In this study, we analyzed the change score of FMA upper limb items score as the primary outcome using the Mixed effects Model for Repeated Measures (MMRM). Consequently, in analysis using the Dunnett test after 10 weeks intervention, there were no significant difference of the change score of FMA upper limb items between three groups in FAS and PPS.
While, we analyzed the change of AOU and QOM score in MAL-14, FMA upper limb item components , ARAT, MI, MAS, ROM, SIS as the secondly outcome between three groups using the MMRM.
Consequently, in analysis using the Dunnett test after 10 weeks intervention, M1 model of the change of the shoulder, elbow, and forearm score in FMA showed significant difference (P=0.037) between the "robotic therapy with usual care group" and "usual care group" in PPS.
Additionally, no significant difference was observed for all other items.
Plan to share IPD
Undecided
IPD sharing Plan description
Undecided
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025480
