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Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain (EHSP)

Primary Purpose

Shoulder Pain

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Wheelchair handrail compensator

Ordinary wheelchair

About this trial

This is an interventional prevention trial for Shoulder Pain focused on measuring Hemiplegia, shoulder pain, wheelchair, stroke, rehabilitation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Specific diagnosis refer to the "China guideline for cerebrovascular disease prevention and treatment"
Course of disease range from two weeks to six months
Age range from 20 to 85 years old
Brunnstrom scale range from I to II
Good mental status and could be able to answer questions

Exclusion Criteria:

Patients with brain trauma, thalamic lesions or peripheral neuropathy
Patients with a history of cervical spondylosis, periarthritis, fracture or trauma at the shoulder, osteoporosis or myocardial infarction which could cause shoulder pain
Patients get worse as a result of cerebral edema or coma following stroke
Patients with serious infection or disorder in heart, liver and kidney
Patients withdraw from the research by themselves

Sites / Locations

Guangdong Provincial Hospital of Chinese medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wheelchair handrail compensator

Ordinary wheelchair

Arm Description

When a patient sitting on the wheelchair, the physiotherapist put the paralysis upper limb on the handrail compensator and keep the limb in normal position for at least 60 minutes one day.

When a patient sitting on the wheelchair, the paralysis upper limb was put on the ordinary handrail for at least 60 minutes one day.

Outcomes

Primary Outcome Measures

Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)

0-66, with higher scores indicating higher function of movement.UE-FM was a well-established stroke motor measure, iteratively determining active movement at each joint of the upper extremity. The UE-FM items were organized into scales that discern isolated movements at increasingly distal upper extremity regions.

Secondary Outcome Measures

Change of Visual Analogue Pain Scale (VAS)

0-10, with higher scores indicating higher degrees of pain.The VAS was commonly used in pain assessment.

Change of Modified Barthel Index (MBI)

0-100, with higher scores indicating higher levels of independence.The Barthel Index (BI) score is a 10-item measure of activities of daily living. It has been proved that the BI has excellent inter-rater reliability for standard administration after stroke. The MBI, modified from BI by Shah, is more sensitive to small changes in functional assessment than the BI.

Change of Quality of Life Index (QLI)

0-5, with higher scores indicating higher quality of life. The QLI is a generic measure for the evaluation of quality of life (QOL) that was initially used in patients with chronic diseases or pain. It has reported that QLI have good reliability and validity in measuring pain disorder.

Full Information

NCT ID

NCT02837068

First Posted

July 11, 2016

Last Updated

July 14, 2016

Sponsor

Guangzhou University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02837068

Brief Title

Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain

Acronym

EHSP

Official Title

Effect and Evaluation: A Randomized Controlled Trial of Wheelchair Handrail Compensator and Rehabilitation Training for Stroke Patients With Shoulder Pain

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether wheelchair handrail compensator plus rehabilitation training could do better than ordinary wheelchair plus rehabilitation training in relieving pain and improving daily life activity, upper limb motor function and quality of life for patients with hemiplegic shoulder pain.

Detailed Description

The ideal management of hemiplegic shoulder pain(HSP) is prevention,and a normal limb position is necessary for preventing and reducing hemiplegic shoulder pain.The foam or board supports has been used to prevent shoulder pain and could be recommended for wheelchair users to keep normal position. Therefore, the investigators designed the equipment wheelchair handrail compensator and expected to help paralyzed limbs to maintain a normal position.Using of the wheelchair handrail compensator may help patients achieve: pain relieve, improvement of upper limb function and increase of the quality of life.The aim of this study was to evaluate the effect of treatment by wheelchair handrail compensator and rehabilitation training for people with hemiplegic shoulder pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

Hemiplegia, shoulder pain, wheelchair, stroke, rehabilitation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wheelchair handrail compensator

Arm Type

Experimental

Arm Description

When a patient sitting on the wheelchair, the physiotherapist put the paralysis upper limb on the handrail compensator and keep the limb in normal position for at least 60 minutes one day.

Arm Title

Ordinary wheelchair

Arm Type

Active Comparator

Arm Description

When a patient sitting on the wheelchair, the paralysis upper limb was put on the ordinary handrail for at least 60 minutes one day.

Intervention Type

Device

Intervention Name(s)

Wheelchair handrail compensator

Intervention Description

Patients were treated by wheelchair handrail compensator for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks. The handrail compensator would help the paralysis upper limb kept the shoulder joint stretch forward, the elbow joint extend, the forearm in pronation, the wrist in flection and the fingers extend.

Intervention Type

Device

Intervention Name(s)

Ordinary wheelchair

Intervention Description

Patients were treated by ordinary wheelchair for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks.The ordinary handrail could prevent the disable arm from sinking, but could not help the upper limp keep a normal position.

Primary Outcome Measure Information:

Title

Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)

Description

Time Frame

Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.

Secondary Outcome Measure Information:

Title

Change of Visual Analogue Pain Scale (VAS)

Description

0-10, with higher scores indicating higher degrees of pain.The VAS was commonly used in pain assessment.

Time Frame

Change of shoulder pain is measured using the Visual Analogue Pain Scale (VAS) from baseline at 4 and 12 weeks.

Title

Change of Modified Barthel Index (MBI)

Description

Time Frame

Change of independence is measured using the Modified Barthel Index (MBI) from baseline at 4 and 12 weeks.

Title

Change of Quality of Life Index (QLI)

Description

Time Frame

Change of quality of life is measured using the Quality of Life Index (QLI) from baseline at 4 and 12 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Specific diagnosis refer to the "China guideline for cerebrovascular disease prevention and treatment" Course of disease range from two weeks to six months Age range from 20 to 85 years old Brunnstrom scale range from I to II Good mental status and could be able to answer questions Exclusion Criteria: Patients with brain trauma, thalamic lesions or peripheral neuropathy Patients with a history of cervical spondylosis, periarthritis, fracture or trauma at the shoulder, osteoporosis or myocardial infarction which could cause shoulder pain Patients get worse as a result of cerebral edema or coma following stroke Patients with serious infection or disorder in heart, liver and kidney Patients withdraw from the research by themselves

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hongxia Chen, MM

Organizational Affiliation

Guangdong Provincial Hospital of Traditional Chinese Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Guangdong Provincial Hospital of Chinese medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain

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