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the Effect of WBPC on Subacute Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
WBPC
Without WBPC
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subacute stroke patient onset 1-3 months, age from 40-80 years-old

Exclusion Criteria:

  • Cognition impaired(MMSE<24), not first-ever stroke, MI history, AF, CHF, NIHSS>12

Sites / Locations

  • Changhua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

With WBPC

Control

Arm Description

Intensive rehabilitation programs :The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks additional WBPC: The duration will be 30 minutes a time

Intensive rehabilitation programs: The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks without WBPC.

Outcomes

Primary Outcome Measures

Functional independent measurement(FIM)
Score from 18 to 126, assessment of degree of disability depends , 18 categories(score from 1~7 points, 1 = <25% independence; total assistance required, 7 = 100% independence), focusing on motor and cognitive function, Represent post-stroke patient's ADL function
Brunnstrom stage,
Stage I to V, stage I: flaccid ; stage II: spasticity appeared, associated movement; stage III: increased spasticity, synnergy movement; stage IV: decreased spasticity, breaking synergy; stgae V:most independent movement; stage VI: normal. Represent post stroke limb function
modified Ashworth Scale,
From 0 to 4 , evaluate post stroke patient's spasticity, 0: No increase in muscle tone; 1: Slight increase in muscle tone;1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3: Considerable increase in muscle tone, passive movement difficult;4: Affected part(s) rigid in flexion or extension

Secondary Outcome Measures

quality of life: short form- 36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

Full Information

First Posted
January 30, 2019
Last Updated
February 14, 2020
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04271891
Brief Title
the Effect of WBPC on Subacute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Whole body periodic acceleration (WBPA) is a head-to-toe movement. The function WBPA works as adding pulses to the circulation. This motion increases shear stress to the endothelium, which stimulates increased release of endothelial-derived nitric oxide (eNO), prostaglandin E-2, tissue plasminogen activator (TPA) into the circulation, and these substances are cardioprotective and contribute to vasodilatation. The WBPA were not well studied than whole body vibration (WBV), a vertical rocking training machine, and most researches focused on cardioprotective effects. A study revealed the effect of Moderate-Intensity Exercise and Whole-Body Periodic Acceleration on Nitric Oxide release was the same. This instrument is quite safe and was applied to patients with varied diseases in previous study. No sound contraindication was mentioned till now. Our hypothesis is assuming that the circulation of brain could improve after the intervention of WBPA, and stroke recovery and cadio-pulmonary function will improve subsequently.
Detailed Description
So the investigators will recruit subacute stroke patients as our subjects. The patient who is booked to our rehabilitation ward for further rehabilitation programs is eligible for our study. the investigators will recruit 30 patients, and randomize them to experimental and control group. This study is going to be single blinded, which the evaluator is blinded to the condition of the subjects. Whether experimental or control groups will received the same intensive rehabilitation programs (6 days a week). The experimental group will receive additional WBPA treatment. The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks. The evaluator will assess twice, before and after the experiment period. The measurements include: muscle power, brunnstrom stages, Barthel Index, functional independence measure (FIM), time up and go test, 6 minutes walk test, Fugl-Meyer Assessment, berg balance scale, cardio-pulmonary test. In addition, to confirm the immediate effect of WBPA over brain circulation, the investigators will choose 6 patients to received carotid ultrasonography before and immediately after the WBPA treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With WBPC
Arm Type
Experimental
Arm Description
Intensive rehabilitation programs :The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks additional WBPC: The duration will be 30 minutes a time
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Intensive rehabilitation programs: The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks without WBPC.
Intervention Type
Device
Intervention Name(s)
WBPC
Intervention Description
The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks.
Intervention Type
Device
Intervention Name(s)
Without WBPC
Intervention Description
Not treat with WBPC
Primary Outcome Measure Information:
Title
Functional independent measurement(FIM)
Description
Score from 18 to 126, assessment of degree of disability depends , 18 categories(score from 1~7 points, 1 = <25% independence; total assistance required, 7 = 100% independence), focusing on motor and cognitive function, Represent post-stroke patient's ADL function
Time Frame
up to 3 weeks
Title
Brunnstrom stage,
Description
Stage I to V, stage I: flaccid ; stage II: spasticity appeared, associated movement; stage III: increased spasticity, synnergy movement; stage IV: decreased spasticity, breaking synergy; stgae V:most independent movement; stage VI: normal. Represent post stroke limb function
Time Frame
up to 3 weeks
Title
modified Ashworth Scale,
Description
From 0 to 4 , evaluate post stroke patient's spasticity, 0: No increase in muscle tone; 1: Slight increase in muscle tone;1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3: Considerable increase in muscle tone, passive movement difficult;4: Affected part(s) rigid in flexion or extension
Time Frame
up to 3 weeks
Secondary Outcome Measure Information:
Title
quality of life: short form- 36
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability
Time Frame
up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subacute stroke patient onset 1-3 months, age from 40-80 years-old Exclusion Criteria: Cognition impaired(MMSE<24), not first-ever stroke, MI history, AF, CHF, NIHSS>12
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

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the Effect of WBPC on Subacute Stroke Patients

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