UMIN-CTR Clinical Trial

Basic information
Public title	An observational study to confirm the effects of different techniques on muscle tone reduction in post-stroke patients.
Acronym	An observational study to confirm the effects of different techniques on muscle tone reduction in post-stroke patients.
Scientific Title	An observational study to confirm the effects of different techniques on muscle tone reduction in post-stroke patients.
Scientific Title:Acronym	An observational study to confirm the effects of different techniques on muscle tone reduction in post-stroke patients.
Region	Japan

Condition
Condition	stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of vibration stimulation therapy on spasticity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Modified Asworth Scale after vibration stimulation therapy and immediately after hand flexion
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	(1)The patient presents with upper extremity dysfunction after a stroke; (2)Spasticity in the upper extremities and a Modified Ashworth Scale of the wrist flexor group of 1 to 3; (3)Those who are 20 years of age or older at the time of obtaining consent; and (4)Persons who have received written consent from themselves or their families to participate in this study.
Key exclusion criteria	(1)Patients with implantable medical electrical devices such as pacemakers; (2)Patients with malignant tumors; (3)Patients with heart defects; (4)Patients who are pregnant or just after giving birth; (5)Patients with paresthesia due to severe peripheral circulatory disorders such as diabetes; (6)those with wounds on the skin; (7)those requiring rest; (8)those with a fever over 38 degrees or higher due to acute inflammatory symptoms (e.g., malaise, chills, blood pressure fluctuations, etc.); (9)those with weakness; (10)those with osteoporosis or acute painful diseases such as spinal fractures, sprains, and separation of the spine; (11)Patients who are prohibited by their physicians from massage due to thrombosis (embolism), severe aneurysms, acute varicose veins, various dermatitis and skin infections (including inflammation of the subcutaneous tissues); (12)Patients with motor dysfunction due to causes other than stroke; (13)Patients with upper extremity contractures; and (14)Patients who are deemed by their physicians or therapists to be unable to perform due to the risk of stroke and other diseases associated with the provision of vibration stimulation.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Kenta Middle name Last name Takeuchi
Organization	Itamikousei Neurosurgical Hospital
Division name	Rehabilitation department
Zip code	6640028
Address	1-300-1 Nishino, Itami-shi, Hyogo
TEL	0727816600
Email	thnkks0304@gmail.com

Public contact
Name of contact person	1st name Kenta Middle name Last name Takeuchi
Organization	Itamikousei Neurosurgical Hospital
Division name	Rehabilitation department
Zip code	6640028
Address	1-300-1 Nishino, Itami-shi, Hyogo
TEL	0727816600
Homepage URL
Email	thnkks0304@gmail.com

Sponsor
Institute	Itamikousei Neurosurgical Hospital
Institute
Department

Funding Source
Organization	none
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	Secretariat of Clinical Trial Review Committee of MINS, a non-profit organization
Address	20-9-401, Mita 5-chome, Mita, Minato-ku, Tokyo
Tel	0364161868
Email	npo-mins@i-irb.com

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	2021 Year 07 Month 31 Day

Related information
URL releasing protocol	N/A
Publication of results	Unpublished

Result
URL related to results and publications	N/A
Number of participants that the trial has enrolled	27
Results	The tendon vibration significantly decreased the MAS of the finger flexor muscles compared with the Stretch and the muscle belly vibration. The muscle belly vibration significantly decreased the MAS scores of the wrist flexor muscles compared with the Stretch and the tendon vibration. The muscle belly vibration provided lasting the effect for reducing spasticity after one voluntary finger flexion compared with the Stretch.
Results date posted	2021 Year 02 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Mean age: 61.3 years (SD: 12.4) Gender: 16 males, 11 females Right hemisphere injury: 12 patients Type of stroke: cerebral infarction 10 patients, cerebral hemorrhage 17 patients, subarachnoid hemorrhage 1 patient First-ever stroke: 23 patients Time from stroke onset to assessment date: 99 days (range 69-168) Brunnstrom Recovery Stage of upper extremity: 8 patients in stage 2, 11 patients in stage 3, 8 patients in stage 4. Brunnstrom Recovery Stage of hand: 8 patients in stage 2, 11 patients in stage 3, 8 patients in stage 4.
Participant flow	Twenty-seven subjects who met the inclusion criteria were included in the analysis.
Adverse events	One patient presented with blushing, hot feeling and swelling as an adverse event after VS for muscle belly. However, these symptoms had improved by the next day.
Outcome measures	The changes in MAS scores for the finger and wrist flexor muscles after each intervention. The Wilcoxon test revealed that significant differences in the MAS scores for finger flexor muscles and wrist flexor muscles between pre and post 1, post 1 and post 2 in each intervention. In treatment for finger flexor muscles, stretch significantly decreased the MAS scores from 2.19 (1.17) to 1.85 (1.29) (p=0.021) between pre and post 1, whereas significantly increased the MAS scores from 1.85 (1.29) to 2.04 (1.02) (p=0.021) between post 1 and post 2. VS for the tendon significantly decreased the MAS scores from 2.20 (1.19) to 1.36 (1.04) (p<0.001) between pre and post 1, whereas significantly increased the MAS scores from 1.36 (1.04) to 1.87 (1.14) (p<0.001) between post 1 and post 2. VS for muscle belly significantly decreased the MAS scores from 1.96 (1.14) to 1.68 (1.14) (p=0.008) between pre and post 1, whereas significantly increased the MAS scores from 1.68 (1.14) to 1.74 (1.14) (p=0.046) between post 1 and post 2. In treatment for wrist flexor muscles, stretch significantly decreased the MAS scores from 2.35 (1.09) to 2.04 (1.22) (p=0.005) between pre and post 1, whereas significantly increased the MAS scores from 2.04 (1.22) to 2.22 (1.0) (p=0.02) between post 1 and post 2. VS for tendon significantly decreased the MAS scores from 2.28 (1.02) to 1.76 (1.13) (p=0.002) between pre and post 1, whereas significantly increased the MAS scores from 1.76 (1.13) to 1.96 (1.15) (p=0.02) between post 1 and post 2. VS for muscle belly significantly decreased the MAS scores from 2.24 (1.05) to 1.64 (1.22) (p=0.001) between pre and post 1, whereas significantly increased the MAS scores from 1.67 (1.22) to 1.87 (1.22) (p = 0.02) between post 1 and post 2. The Wilcoxon test revealed that no significant differences in the MAS scores for finger flexor muscles and wrist flexor muscles between pre and post 2 in each intervention. When we consider that compare the change in the MAS scores among three interventions, in treatment for finger flexor muscles, we observed that VS for the tendon greatly decreased the MAS scores compared with the Stretch (p=0.005), VS for the muscle belly (p=0.002). In treatment for wrist flexor muscles, VS for the muscle belly greatly decreased the MAS scores compared with the Stretch (p=0.01), VS for the tendon (p=0.005). We observed that VS for the muscle belly provided lasting the effect for decreasing spasticity after voluntary finger flexion movement compared with the Stretch (p=0.021). Next, in order to clarify the effect of each intervention on spasticity, we also used the responder rate. In treatment for finger flexor muscles, the McNemar test shows that the responder rate of VS for the tendon (68%) was significantly higher than that of Stretch (31%) and VS for the muscle belly (28%) (p=0.012, p=0.004, respectively). These results demonstrate that the tendon vibration was most effective treatment for spasticity of finger flexor muscles. In treatment for wrist flexor muscles, although no significant at post 1, the responder rate of VS for muscle belly (39%) was higher than that of Stretch (13%) at post 2 (p=0.031). These results demonstrate that the muscles belly vibration may provide lasting the effect for decreasing spasticity after one voluntary finger flexion movement.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 26 Day
Date of IRB	2018 Year 10 Month 17 Day
Anticipated trial start date	2018 Year 10 Month 26 Day
Last follow-up date	2019 Year 03 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1. Study design: cohort study 2. eligibility method: patients admitted to the facility between November 1, 2018 and March 24, 2019 who meet the selection criteria. 3. Survey items: (1) Patient background: age, gender, dominant hand, disabled hand, date of stroke, stroke type, previous stroke, antispasticity medication use, upper extremity and hand Brunnstrom Recovery Stage (2) Modified Ashworth Scale(MAS)of hand and wrist flexors 4. Implementation of muscle tension reduction and evaluation of muscle tension The following procedure will be used to perform muscle tone reduction and assess muscle tone status in subjects who have given consent to participate in this study. This procedure will be performed for a minimum of three days per subject until at least one of the three methods described below is performed. (1) Selection of muscle tone reduction methods. Depending on the subject's muscle tone and the nature of the day's training, select one of the following contraction control methods Upper extremity stretching only. Stretching of the upper limb and vibration stimulation of the forearm tendon Stretching of the upper limbs and vibration stimulation of the forearm abdomen (2) MAS Rating After placing the subject in the supine position, the MAS assessment will be performed and the date and results of the MAS assessment will be entered on the "Assessment Form". (3) Implementation of muscle tension reduction After the MAS assessment, muscle tone reduction is performed in the supine position using the selected method. Upper extremity stretching only Stretch the upper extremity and stimulate the forearm tendon area with vibration Stretching of the upper extremity and vibration stimulation of the forearm abdomen.

Management information
Registered date	2021 Year 02 Month 27 Day
Last modified on	2021 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046958