UMIN-CTR Clinical Trial

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

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Modified Asworth Scale after vibration stimulation therapy and immediately after hand flexion

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Itamikousei Neurosurgical Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

07

Month

31

Day

URL releasing protocol

N/A

Publication of results

Unpublished

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

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 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.

Registered date

2021

Year

02

Month

27

Day

Last modified on

2021

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046958