Shoulder Passive Range of Motion and Positioning Exercise on Hemiplegic Stroke Patients

February 5, 2017 updated by: Chang Gung Memorial Hospital

Passive Range of Motion and Position Training for Stroke Patients With Hemiplegia to Prevent Shoulder Injury or Pain- Ultrasonographic Study

Several factors associated with the hemiplegic shoulder pain after stroke includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. In this study, the investigators aim to usie high frequency ultrasound to evaluate the relationship between stroke patients with poor shoulder motor function and shoulder tendon injury. Also, assumed that performing passive range of motion and positioning training might prevent tendon injury of shoulder and hemiplegic shoulder pain in either acute or chronic stage of stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hemiplegic shoulder pain is a common complication. Several factors associated with the hemiplegic shoulder pain includes rotator cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and brachial/axillary neuropathy. Flaccidity has a positive association with soft tissue injury or tendon injury of the shoulder.

In the preliminary study, base on the sonography results, it is found that the possibility of getting tendon injury or inflammation on the affected shoulder joint is higher in the group of patients who were with worse motor functions during the rehabilitation in hospital.

In this study, one hundred acute stroke patients with hemipelgia will be enrolled. And those participants would be separated into 2 groups: control group (Brunnstrom stage IV-VI) and experimental group (Brunnstrom stage I-III). Clinical characteristics and physical findings will be recorded on the admission date. During the process, the investigators will use high frequency (5-12 MHz) musculoskeletal ultrasound to evaluate those tendons around bilateral shoulder joints on the admission date and at 2 weeks later. In the first year after stroke, half patients in those 2 groups will perform positioning training and passive range of motion for affected shoulder either during hospitalization or after being discharged. Then, the investigators will execute physical examination and use high frequency ultrasound to evaluate those tendons around bilateral shoulder joints of the participants twice after 6 months and 12 months. Then, the investigators will discuss the incidences of shoulder tendon injury after receiving rehabilitation program according to ultra-sonographic findings.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stroke with hemiplegia
  • age between 18-80

Exclusion Criteria:

  • recurrent stoke patient
  • previous history of shoulder pain, any injuries and operation in shoulder joint, frozen shoulder, tendinitis in shoulder joint,
  • any other systemic neuromuscular disease
  • cognition or language impairment leading to communication difficulty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: video-teaching materials
  • regular passive ROM exercise
  • regular rehabilitation programe
  • alternative video-teaching materials
Other: video-teaching
By watching a video specially designed by a rehabilitation team, the participants may learn how to position their affected arm properly (30 minutes per time, twice a day for five days in a week), how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly (15 minutes per time, twice a day for five days in a week), and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy.
Other: oral-teaching
The nurses will teach patients how to position their affected arm properly, how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly, and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy on the admission date of hospitalization.
Other: regular rehabilitation program
Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.
Other: control group
  • regular passive ROM exercise
  • regular rehabilitation programe
  • regular oral-teaching materials
Other: oral-teaching
The nurses will teach patients how to position their affected arm properly, how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly, and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy on the admission date of hospitalization.
Other: regular rehabilitation program
Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change from baseline on hemiplegic upper extremity sonography
Time Frame: baseline (before intervention), changes from baseline sonography results at one week before being discharged and at six month after.
A doctor will use a high frequency(5-12 MHz) sonography examination machine(Terason t300, Teratech Co., USA) as the evaluation tool of this study. The target muscles and structures around affected shoulder includes biceps, supraspinatus, infraspinatus, subscapularis, sub-deltoid bursa and ACJ.
baseline (before intervention), changes from baseline sonography results at one week before being discharged and at six month after.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brunnstrom motor recovery stage for motor ability
Time Frame: baseline (before intervention), changes from baseline Brunnstrom stage at one week before being discharged and at six month after.
A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till one week before being discharged and after six months.
baseline (before intervention), changes from baseline Brunnstrom stage at one week before being discharged and at six month after.
Modified Ashworth scale for level of spasticity of affected arm
Time Frame: baseline (before intervention), changes from baseline level of spasticity at one week before being discharged and at six month after.
A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.
baseline (before intervention), changes from baseline level of spasticity at one week before being discharged and at six month after.
Range of motion
Time Frame: baseline (before intervention), changes from baseline range of motions at one week before being discharged and at six month after.
A physical therapist will measure range of motions of affected arm by using goniometry.
baseline (before intervention), changes from baseline range of motions at one week before being discharged and at six month after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yu Chi Huang, Bachelor, Study Principal Investigator ChangGungMH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Actual)

July 31, 2008

Study Completion (Actual)

June 30, 2009

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 5, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRPG866091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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