Condition category
Circulatory System
Date applied
11/10/2010
Date assigned
19/10/2010
Last edited
19/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Young-Keun Woo

ORCID ID

Contact details

Department of Physical Therapy
Andong Science College
496 Kyu-ri SeoHu-Myeon
Andong City
Gyeongsangbuk-do
760-709
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009-44

Study information

Scientific title

Effects of Spring Assisted Dynamic Hand Orthosis Training on Functions and Movement Smoothness of the Hemiparetic Upper Extremity: A randomised controlled trial

Acronym

SADHO

Study hypothesis

The purpose of this experiment was to evaluate the effectiveness of training using a spring assisted dynamic hand orthosis on smoothness of movement, clinical assessment score, and grip strength of the affected limb in hemiparetic patients. To determine resultant velocity and jerkiness score for movement smoothness, the Box and Block Test (BBT), Action Research Arm Test (ARAT), and Fugl-Meyer Assessment (FMA) for functions of the hemiparetic upper extremity were conducted.

Ethics approval

Yonsei University, College of Medicine approved on the 25th of March 2010 (ref: 2009-44)

Study design

Randomised comparative interventional pretest-posttest control group design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Hemiparesis due to Stroke

Intervention

Patients will undergo training activities while each wore a spring assisted dynamic hand orthosis. Training will be guided by a physiotherapist for 1 hour per day per week for 4 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

3 clinical assessments and the measurement of grip strength. Fugl-Meyer Assessment and grip strength and Action Research Arm Test and Box and Block Test.
All outcomes were measured at baseline and after 4 weeks of training.

Secondary outcome measures

Spatiotemporal parameters were collected using a 3-D motion analysis system and workstation software pre- and post-test (VICON MX system, Oxford Metrics, U.K.). Data collection was conducted at the Motion Analysis Research Laboratory in the Yonsei University.
All outcomes were measured at baseline and after 4 weeks of training.

Overall trial start date

23/12/2009

Overall trial end date

15/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years or older
2. Unilateral hemiparesis more than 6 months post-stroke duration
3. No current or previous orthopedic or surgical histories affecting the hemiparetic upper extremity
4. Mini-Mental State Examination (MMSE) Korean version - score ≥ 23 (to ensure that they fully understood the study procedure)
5. Patients should have at least some active voluntary movement of the upper extremity (i.e., 10 degrees of shoulder flexion/abduction, 10 degrees of elbow flexion/extension, and 30 degrees of interphalangeal proximal joints / 20 degrees of interphalangeal distal joints of volitional finger flexion when the hand is positioned in wrist and finger extension)
6. No flaccidity of the affected limb
7. No severe contracture or spasticity of the affected wrist or hand

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

23/12/2009

Recruitment end date

15/03/2010

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Physical Therapy
Gyeongsangbuk-do
760-709
Korea, South

Sponsor information

Organisation

Yonsei University College of Medicine (South Korea)

Sponsor details

c/o Young-Keun Woo
Department of Physical Therapy
Andong Science College
496 Kyu-ri SeoHu-Myeon
Andong City
Gyeongsangbuk-do
760-709
Korea
South

Sponsor type

Not defined

Website

Funders

Funder type

Other

Funder name

Investigator funded (South Korea) - Dissertation project

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes