Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000483358
Ethics application status
Approved
Date submitted
1/02/2016
Date registered
3/04/2017
Date last updated
11/03/2019
Date data sharing statement initially provided
11/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of hip extensor and abductor taping on gait performance in chronic stroke patients with long-term use of a cane: a randomized controlled trial
Scientific title
Effect of hip extensor and abductor taping on gait performance in chronic stroke patients with long-term use of a cane: a randomized controlled trial
Secondary ID [1] 288202 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 297483 0
Condition category
Condition code
Stroke 298980 298980 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A. Experimental group: Leuko@ tape on hip extensor and abductor of affected side limb. Control group: sham tape. After the taping applied, both groups will received the same exercise program include: muscle strength strengthening, balance training, treadmill training . The 12 session will be conducted in 3 times weekly about 50 min for 4 weeks. All of the sessions is individual one-on-one sessions by one physiotherapist at the study site gym.
(a) Muscle strengthening program (15 min): subjects will doing hip extension (e.g. bridging), hip abduction in supine and side lying position on mat. Each movement will doing 10 repetition for 3 times. The resistance will be given with theraband on the lower extremities. The exercise intensity will be adjusted at 12-14/20 RPE.
(b) Balance training (15 min): subject will doing both static balance and dynamic balance movement like one-leg standing, tandem walk, kick ball, etc. Each movement will doing 3-5 times, focused on the quality of motor control.
(c) Treadmill training (15 min): treadmill speed started from 0.1 kph to comfortable gait speed. The intensity set at 12-14/20 RPE. The speed will be increasing step by step depended on the tolerance of subjects in 4 weeks.
The Taping procedure below:
a) Leuko@ tape have been proved that could provide properioception input, improve joint alignment and facilitate muscle firing. In this clinical trial, we use the Leuko@ tape to assist stroke patients to support affected lower limb on more weight bearing position.
b) A physical therapist place the tape without any tension on the skin, but stabilize the muscle belly of hip muscle group in a shorten position. There are six bands on the hip extensors, and hip abductors. For the hip extensors, the first band from the medial aspect of the gluteal fold, pulled laterally and superiorly towards the greater trochanter. The second band from the medial aspect of the gluteal fold to the top of the buttock above the gluteus maximus muscle belly, lifting the buttock. The third band, from the superior end of the second piece of tape to the greater trochanter. For hip abductors, three bands of taping were applied from just below the greater trochanter. The first bands, directly upwards to the iliac crest. The second bands, upwards and anteriorally to the anterior superior iliac spine. The third bands, upwards and posteriorally towards the posterior third of the iliac crest.

c) We changes a new tape at each training.
d) We check the adherence by phone every day.
Intervention code [1] 293785 0
Treatment: Other
Intervention code [2] 297609 0
Rehabilitation
Comparator / control treatment
We use the protection(skin) tape to be sham tape, this protection tape is very soft and no any property like Leuko@ tape. These subjects will also complete the exercise program.
Control group
Placebo

Outcomes
Primary outcome [1] 297210 0
We use the OPTOGait system to record the self-selected gait speed
Timepoint [1] 297210 0
1) baseline and post-taping assessment (immediately assess after taping placement for the first time)
2) After the 4 weeks intervention
3) 1 month follow up after the intervention finished
Secondary outcome [1] 320358 0
Balance, assessed using the Berg Balance Scale
Timepoint [1] 320358 0
1) baseline and post-taping assessment (immediately assess after taping placement for the first time)
2) After the 4 weeks intervention
3) 1 month follow up after the intervention finished
Secondary outcome [2] 324166 0
muscle strength, assessed using the hand-hled dyanometer
Timepoint [2] 324166 0
1) baseline and post-taping assessment (immediately assess after taping placement for the first time)
2) After the 4 weeks intervention
3) 1 month follow up after the intervention finished
Secondary outcome [3] 324167 0
Physical endurance, assessed using the 6 minutes walking test
Timepoint [3] 324167 0
1) baseline and post-taping assessment (immediately assess after taping placement for the first time)
2) After the 4 weeks intervention
3) 1 month follow up after the intervention finished

Eligibility
Key inclusion criteria
Age: 20-80 years old
onset of stroke more than 6 months previously
Functional Category Ambulation over 3 point
Minimal Mental State Examination over 24 point
Long-term users of a cane: using regular cane or quadricane over 6 months
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
allergy to adhesive sports tape, Modified Ashworth Scale over 2 point of affected lower limb

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/12/2015
Date of last participant enrolment
Anticipated
31/05/2018
Actual
7/03/2017
Date of last data collection
Anticipated
31/07/2018
Actual
31/05/2018
Sample size
Target
50
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 7564 0
Taiwan, Province Of China
State/province [1] 7564 0
Taipei

Funding & Sponsors
Funding source category [1] 292799 0
Hospital
Name [1] 292799 0
Taipei City Hospital
Country [1] 292799 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
National Yang Ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 291539 0
Hospital
Name [1] 291539 0
Taipei City Hospital
Address [1] 291539 0
N0. 145, Zhengzhou Rd., Datong Dist., Taipei City 10341, Taiwan (R.O.C.)
Country [1] 291539 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294301 0
Taipei City Hospital Institutional Review Board
Ethics committee address [1] 294301 0
Ethics committee country [1] 294301 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294301 0
01/08/2015
Approval date [1] 294301 0
23/11/2015
Ethics approval number [1] 294301 0
TCHIRB-10409103

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 743 743 0 0
/AnzctrAttachments/369824-Abstract_conference 2016.doc

Contacts
Principal investigator
Name 62354 0
Ms Jyue Liang, Chen
Address 62354 0
National Yang Ming University Department of Physical Therapy and Assistive Technology. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 62354 0
Taiwan, Province Of China
Phone 62354 0
+886935965087
Fax 62354 0
Email 62354 0
[email protected]
Contact person for public queries
Name 62355 0
Chieh Yu, Lin
Address 62355 0
National Yang Ming University Department of Physical Therapy and Assistive Technology. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 62355 0
Taiwan, Province Of China
Phone 62355 0
+886923632236
Fax 62355 0
Email 62355 0
[email protected]
Contact person for scientific queries
Name 62356 0
Jyue Liang, Chen
Address 62356 0
National Yang Ming University Department of Physical Therapy and Assistive Technology. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 62356 0
Taiwan, Province Of China
Phone 62356 0
+886935965087
Fax 62356 0
Email 62356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAdjunct Non-Elastic Hip Taping Improves Gait Stability in Cane-Assisted Individuals with Chronic Stroke: A Randomized Controlled Trial.2022https://dx.doi.org/10.3390/jcm11061553
N.B. These documents automatically identified may not have been verified by the study sponsor.