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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Shoulder Pain
Rotator Cuff Injury
Stroke
Hemiplegia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03045432
NMRPG866091

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

104 participants in 2 patient groups

video-teaching materials
Experimental group
Description:
* regular passive ROM exercise * regular rehabilitation programe * alternative video-teaching materials
Treatment:
Other: oral-teaching
Other: regular rehabilitation program
Other: video-teaching
control group
Other group
Description:
* regular passive ROM exercise * regular rehabilitation programe * regular oral-teaching materials
Treatment:
Other: oral-teaching
Other: regular rehabilitation program

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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