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

NCT03045432 | Completed

• 1 other identifier: NMRPG866091
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Shoulder Pain; Hemiplegia; Stroke; Rotator Cuff Injury

Keywords

Stroke; Hemiplegia; Rotator Cuff Injury

Outcome Measures

Primary Outcomes (1)

• the change from baseline on hemiplegic upper extremity sonography

  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 Outcomes (3)

• Brunnstrom motor recovery stage for motor ability

  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

  baseline (before intervention), changes from baseline level of spasticity at one week before being discharged and at six month after.

• Range of motion

  baseline (before intervention), changes from baseline range of motions at one week before being discharged and at six month after.

Study Arms (2)

video-teaching materials

EXPERIMENTAL

* regular passive ROM exercise * regular rehabilitation programe * alternative video-teaching materials

Other: video-teaching; Other: oral-teaching; Other: regular rehabilitation program

control group

OTHER

* regular passive ROM exercise * regular rehabilitation programe * regular oral-teaching materials

Other: oral-teaching; Other: regular rehabilitation program

Interventions

video-teaching OTHER

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.

video-teaching materials

oral-teaching OTHER

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.

control group; video-teaching materials

regular rehabilitation program OTHER

Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.

control group; video-teaching materials

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stroke with hemiplegia
• age between 18-80

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (24)

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• Brandt TD, Cardone BW, Grant TH, Post M, Weiss CA. Rotator cuff sonography: a reassessment. Radiology. 1989 Nov;173(2):323-7. doi: 10.1148/radiology.173.2.2678248.

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• Pong YP, Wang LY, Wang L, Leong CP, Huang YC, Chen YK. Sonography of the shoulder in hemiplegic patients undergoing rehabilitation after a recent stroke. J Clin Ultrasound. 2009 May;37(4):199-205. doi: 10.1002/jcu.20573.

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MeSH Terms

Conditions

Shoulder Pain; Hemiplegia; Stroke; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Yu Chi Huang, Bachelor

  Study Principal Investigator ChangGungMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 7, 2017
• Study Start: August 1, 2007
• Primary Completion: July 31, 2008
• Study Completion: June 30, 2009
• Last Updated: February 7, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share