Kinematic Motion Analyses of Upper Extremity After Intensive Training with Spring-assisted Dynamic Hand Orthosis in Patient with Stroke
| ISRCTN | ISRCTN67543440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67543440 |
| Protocol serial number | 2009-44 |
| Sponsor | Yonsei University College of Medicine (South Korea) |
| Funder | Investigator funded (South Korea) - Dissertation project |
- Submission date
- 11/10/2010
- Registration date
- 19/10/2010
- Last edited
- 19/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Young-Keun Woo
Scientific
Scientific
Department of Physical Therapy
Andong Science College
496 Kyu-ri SeoHu-Myeon
Andong City
Gyeongsangbuk-do
760-709
Korea, South
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised comparative interventional pretest-posttest control group design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of Spring Assisted Dynamic Hand Orthosis Training on Functions and Movement Smoothness of the Hemiparetic Upper Extremity: A randomised controlled trial |
| Study acronym | SADHO |
| Study objectives | 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(s) | Yonsei University, College of Medicine approved on the 25th of March 2010 (ref: 2009-44) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 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. |
| Completion date | 15/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 23/12/2009 |
| Date of final enrolment | 15/03/2010 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Department of Physical Therapy
Gyeongsangbuk-do
760-709
Korea, South
760-709
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
