Status Approved
First Submitted Date
2017/04/24
Registered Date
2017/05/19
Last Updated Date
2017/05/15
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002335 |
---|---|
Unique Protocol ID | 1041849-201610-BM-055-02 |
Public/Brief Title | Immediate Effects of Talus-Stabilizing Taping on Balances and Gait Parameters in Chronic Stroke Patients |
Scientific Title | Immediate Effects of Talus-Stabilizing Taping on Balances and Gait Parameters in Chronic Stroke Patients |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | 1041849-201610-BM-055-02 |
Approval Date | 2016-11-01 |
Institutional Review Board Name | Yonsei University Wonju Institutional Review Board |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Heon-seock Cynn |
Title | PhD. |
Telephone | +82-33-760-2427 |
Affiliation | Yonsei University |
Address | Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea |
Contact Person for Public Queries | |
Name | DONGHWAN PARK |
Title | Mr. |
Telephone | +82-32-899-4559 |
Affiliation | Yonsei University |
Address | Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea |
Contact Person for Updating Information | |
Name | DONGHWAN PARK |
Title | Mr. |
Telephone | +82-32-899-4559 |
Affiliation | Yonsei University |
Address | Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Completed | |
Date of First Enrollment | 2016-11-14 Actual | |
Target Number of Participant | 20 | |
Primary Completion Date | 2016-11-18 , Actual | |
Study Completion Date | 2016-11-30 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Gyeongin Rehabilitaion Center Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2016-11-14 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Yonsei University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
Lay Summary | Objective Our objective is to compare the immediate effects of ankle talus-stabilizing taping with those of barefoot and conventional ankle-foot orthosis on balance and gait parameters in patients with chronic stroke. Background: Stroke is currently the leading cause of long-term disability because of the sequelae experienced by patients with stroke, which further impairs lower limb function and thus influences walking. There are many training approaches for improving balance and gait performance through reducing the ankle plantar flexor passive resistance using assistive treatment methods, such as robotic devices, functional electric stimulation, ankle-foot orthoses, and ankle mobilization with movement.Talus-stabilizing taping can be used to improve ankle range of motion and gait performance because it provides a posterior-inferior talar glide in a closed-chain dorsiflexion position. No previous studies have investigated the usefulness of talus-stabilizing taping in patients with chronic stroke. Recent studies reported that talus-stabilizing taping improves ankle range of motion and gait performance because talus-stabilizing taping provides a posterior-inferior talar glide in a closed-chain dorsiflexion position Hypothesize : We hypothesized that talus-stabilizing taping would improve static balance ability, timed up and go test, gait parameters in the patients with chronic stroke. Plan : The order of conditions (talus-stabilizing taping , barefoot, and conventional ankle-foot orthosis) was determined using the web randomization site, and each patient performed the tests under the three conditions in random order to avoid bias through learning or fatigue. An experienced physical therapist was blinded to the patient intervention assignments and study hypotheses, limiting the potential for expectation bias. The patient characteristics and all outcome (static balance ability, timed up and go test, and gait parameters) measures were assessed by the same physical therapist. The measurements were repeated three times, and the mean value was calculated. |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Treatment |
Phase | Phase3 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Medical Device |
Intervention Description | The order of conditions (talus-stabilizing taping, barefoot, and conventional ankle-foot orthosis (S, M, L size)) was determined using the web randomization site, and each patient performed the tests under the three conditions in random order. The patient characteristics and all outcome (static balance ability, timed up and go test, and gait parameters) measures were assessed by the physical therapist. |
Number of Arms | 1 |
Arm 1 |
Arm Label experimental group |
Target Number of Participant 20 |
|
Arm Type Experimental |
|
Arm Description The order of conditions (TST, barefoot, and conventional AFO) was determined using the web randomization site, http://www.randomization.com, and each patient performed the tests under the three conditions in random order. 1) For the talus-stabilizing taping, the patients placed the affected side ankle on the chair and advanced the tibia over the foot via knee flexion. An experienced physical therapist used protective under-tapes. A rigid strapping tape (37 mm width, Mueller M tape) was applied from the talus of the affected side ankle (passing below the medial and lateral malleolus) to the plantar surface of the calcaneus through the medial and lateral sides of the talus using maximal force with the tape. 2) The conventional ankle-foot orthosis used in this study was a standard, off-the-shelf, posterior leaf type, with a setting in neutral position. The orthosis came in three different sizes, and the one that best fitted each patient was used. 3) Measurements were made with bare feet. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I64)Stroke, not specified as haemorrhage or infarction |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 43Year~78Year |
|
Description (1) diagnosis of hemiplegia due to hemorrhagic or ischemic stroke; more than 6 months post-stroke to minimize the effects of natural recovery; (2) independent gait possible over 10 m without assistive devices (3) minimum score of 24 on the Korean Mini-Mental State Examination (4) spasticity in a lower affected side ankle (Modified Ashworth scale≤1) (5) no orthopedic problems involving the lower extremities that would affect gait. |
|
Exclusion Criteria |
(1) medical problems other than neurological lesions that affected the gait patterns (2) bilateral affected limbs (3) premorbid or current orthopedic problem involving the lower extremities. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | static balance ability |
|
Timepoint | The patients performed the tests for 10 min to familiarize themselves with the three conditions until a proper motion in walking was achieved at a comfortable speed. A 5-min resting period was allowed after the familiarization period and before the data collection began. |
|
Primary Outcome(s) 2 | ||
Outcome | Timed up and go test |
|
Timepoint | The patients performed the tests for 10 min to familiarize themselves with the three conditions until a proper motion in walking was achieved at a comfortable speed. A 5-min resting period was allowed after the familiarization period and before the data collection began. |
|
Secondary Outcome(s) 1 | ||
Outcome | gait parameters |
|
Timepoint | The patients performed the tests for 10 min to familiarize themselves with the three conditions until a proper motion in walking was achieved at a comfortable speed. A 5-min resting period was allowed after the familiarization period and before the data collection began |
11. Study Results and Publication
Result Registered |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
---|
TOP
BOTTOM
화면 최하단으로 이동