A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Device: Self-designed surface functional electrical stimulator |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation |
- Upward migration index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Acromiohumeral distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: shoulder FES treatment |
Device: Self-designed surface functional electrical stimulator
Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.
Other Name: Self-designed surface functional electrical stimulation
|
Detailed Description:
Functional electrical stimulation (FES) is a common and effective therapeutic approach for clinical treatments of shoulder subluxation. By applying low-frequency electrical stimulation to the target muscle groups, improvements may be observed in terms of muscle strength, subluxation, and passive humeral lateral rotation of the shoulder joint. In order to overcome issues regarding the integration of an FES and a rehabilitation robot, group members have designed a customized FES system approved by medical safety regulations. Despite sharing identical specifications with commercial models, the approved 2-channel FES system provides better integrity and control when working with the upper extremity rehabilitation robot. In this study, three patients with unilateral shoulder subluxation will be recruited. Limited shoulder x-ray photos shall be taken before, during, and after the FES shoulder subluxation treatment for studying the effects.
Eligibility| Ages Eligible for Study: | 25 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- stroke (1-3 months)
- Brunnstrom Stage I-III
- single, unilateral
Exclusion Criteria:
- aphasic
- shoulder impairment
- severe osteoporosis
- cardiac arrhythmias or having a pacemaker implanted
- abnormal cutaneous sensation at the target areas
Contacts and Locations| Contact: Jin-Shin Lai | +886-2-23123456 ext 66583 | jslai@ntu.edu.tw |
| Taiwan | |
| Department of Physical Medicine and Rehabilitation, NTUH | Recruiting |
| Taipei, Taiwan | |
| Contact: Jin-Shin Lai 886-2-23123456 ext 66583 jslai@ntu.edu.tw | |
| Principal Investigator: Jin-Shin Lai, MD | |
| Principal Investigator: | Jin-Shin Lai, MD | Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan |
More Information
No publications provided
| Responsible Party: | Jin-Shin Lai, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01139034 History of Changes |
| Other Study ID Numbers: | 201002029D |
| Study First Received: | June 7, 2010 |
| Last Updated: | June 20, 2010 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Stroke Dislocations Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013