the Effect of WBPC on Subacute Stroke Patients

NCT ID: NCT04271891

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

With WBPC

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

Group Type: EXPERIMENTAL

WBPC

Intervention Type: DEVICE

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.

Control

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.

Group Type: PLACEBO_COMPARATOR

Without WBPC

Intervention Type: DEVICE

Not treat with WBPC

Interventions

WBPC

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

Without WBPC

Not treat with WBPC

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei-Te Wang

Attending physician of physical medicine and rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Changhua Christian Hospital

Changhua, , Taiwan

Countries

Taiwan

Other Identifiers

100-CCH-IRP-62

Identifier Type: -

Identifier Source: secondary_id

CCH_101101

Identifier Type: -

Identifier Source: org_study_id