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

NCT02837068 | Completed DMC

• 1 other identifier: 2012B091100487
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Hemiplegia; shoulder pain; wheelchair; stroke; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Change of Visual Analogue Pain Scale (VAS)

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

• Change of Modified Barthel Index (MBI)

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

• Change of Quality of Life Index (QLI)

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

Study Arms (2)

Wheelchair handrail compensator

EXPERIMENTAL

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.

Device: Wheelchair handrail compensator

Ordinary wheelchair

ACTIVE COMPARATOR

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

Device: Ordinary wheelchair

Interventions

Wheelchair handrail compensator DEVICE

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.

Wheelchair handrail compensator

Ordinary wheelchair DEVICE

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.

Ordinary wheelchair

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese medicine

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Shoulder Pain; Hemiplegia; Stroke

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

Study Officials

• Hongxia Chen, MM

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 19, 2016
• Study Start: December 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)