UMIN-CTR Clinical Trial

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
Email	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
Email	domen@neuro-reha.org

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025480