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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00167089
Other study ID # 47s1
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated October 5, 2009
Start date August 1998
Est. completion date August 2000

Study information

Verified date September 2009
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to explore an alternative approach that emphasizes task specificity and treadmill training for ambulation training of these patients.


Description:

Restoration of independent ambulatory ability is one of the most common functional goals of patients with hemiplegia after stroke. Ambulation training, therefore, is an important part of physical therapy intervention for these patients. Conventional neurologic physical therapy for ambulation training, based sorely on neurophysiology, prohibits early ambulation experience after stroke in attempt to avoid the development of abnormal gait patterns. Such an approach has been shown to be limited in helping these patients regain independent ambulatory ability.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2000
Est. primary completion date August 2000
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- between 40 and 75 years old

- first stroke with R't side hemiplegia due to middle cerebral artery occlusion and received acute treatment at NTUH

- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

- able to ambulate independently in parallel bars and having no independent ambulation ability outside parallel bars

Excursion criteria:

- having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters

- having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases other than stroke

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Treadmill Training
Partian body weight support treadmill training, 30 min/day * 3 days /week

Locations

Country Name City State
Taiwan School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University Taipei Province of China

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate walking speed and stride length as the representation of ambulation ability 3 months No
Secondary To investigate the the co-activation duration between the activity of hamstring and quadriceps, and tibialis anterior and gastrocnemius joints, the level of symmetry in step length and stance/swing duration ratio between the affected and unaffected legs 3 months No
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