NCT04271891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

3.7 years

First QC Date

January 30, 2019

Last Update Submit

February 14, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

  • 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

    up to 3 weeks

  • 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

    up to 3 weeks

  • 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

    up to 3 weeks

Secondary Outcomes (1)

  • quality of life: short form- 36

    up to 3 weeks

Study Arms (2)

With WBPC

EXPERIMENTAL

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

Device: WBPC

Control

PLACEBO COMPARATOR

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.

Device: Without WBPC

Interventions

WBPCDEVICE

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.

With WBPC
Without WBPCDEVICE

Not treat with WBPC

Control

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician of physical medicine and rehabilitation

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 17, 2020

Study Start

April 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

TW(1)