Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001710415
Ethics application status
Approved
Date submitted
23/11/2016
Date registered
13/12/2016
Date last updated
13/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparisons between Novel Medical Hand Gloves and Traditional Elastic Bandages as Measured by Changes in Body Temperature during Stroke Patients’ Use of Upper Body Rehabilitation Equipment
Scientific title
Comparisons between Novel Medical Hand Gloves and Traditional Elastic Bandages as Measured by Changes in Body Temperature during Stroke Patients’ Use of Upper Body Rehabilitation Equipment
Secondary ID [1] 290614 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 301107 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300878 300878 0 0
Physiotherapy
Stroke 300956 300956 0 0
Ischaemic
Stroke 300957 300957 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
“Yole Hand” is a set of specially designed assistive device for use in rehabilitation clinics in the treatment of stroke patients with paralyzed upper limbs. Yole Hands are made with material that breathe very well. Each Yole Hand consists of a Velcro half glove, a fastening strap, and a security strap. Yole Hands have been designed to distribute pressure over the dorsal edges and the palms of patients’ hands. This design reduces skin friction and risks of soft tissue damage, maintains proper blood circulation, and facilitates active hand grasp. Moreover, Yole Hands have been patented (M485716) and approved for medical applications by the Ministry of Health and Welfare of Taiwan (No. 005771).

Eighteen subjects were recruited from a rehab clinic in the south of Taiwan. Each subject performed upper-limb exercises using rehabilitation equipment made by Sinwanai of Taiwan, with Yole hands and with elastic bandages. The selection of either Yole Hands or elastic bandages to secure the subject’s affected hand to the exercise equipment was made in random order. After the initial test, each subject was allowed to rest for a day before conducting the second test.

The Sinwanai exercise equipment is a commonly-used equipment in rehabilitation clinics in Taiwan because it allows stroke patients with paralyzed limbs to perform passive upper and lower limb exercises. The Sinwanai exercise equipment is an automatic electronic equipment with two handles and two pedals to allow patients to passively perform their shoulder, elbow flexion/extension and hip, knee flexion/extension movements with adjustable speed and duration.

A physical therapist, other than the primary investigator, put Yole Hand on the subject’s affected hand and attached a fastening strap to the handle of the Sinwanai exercise equipment. The patient’s affected hand wearing Yole Hand was then affixed to the fastening strap with Velcro. Another security strap was placed on top of Yole Hand to prevent the subject’s hand from detaching from the exercise equipment. The physical therapist supervised all subjects’ skin temperature during the entire duration of their exercises. The physical therapist controlled the settings of the Sinwanai exercise equipment and was prepared to turn off power to the equipment immediately if needed.
Intervention code [1] 296475 0
Rehabilitation
Intervention code [2] 296551 0
Treatment: Devices
Comparator / control treatment
The aim of this research is to compare the skin temperature change in stroke patients’ hands while operating exercise equipment with Yole hands and with elastic bandages on the affected hand.(only one group)
Control group
Active

Outcomes
Primary outcome [1] 300282 0
The temperature sensors were placed by a researcher onto the subject’s thumbs, positioned 1/3 of the way down on the distal thumb.
We compared the differences in skin temperature on the patients’ affected and unaffected thumbs of upper extremity during and after their use of the exercise equipment, with Yole hands and with elastic bandages by temperature measuring instrument.(GL220,Japan)
Timepoint [1] 300282 0
The subject’s hand temperature was recorded throughout the entire exercise, before exercise and 5 minutes after completing the exercise.
Secondary outcome [1] 329611 0
none
Timepoint [1] 329611 0
none

Eligibility
Key inclusion criteria
(1) age 30 or older;
(2) first time stroke patient;
(3) stroke patients in the subacute stage;
(4) Brunnstrom stage I-IV of upper limbs;
(5) scores of Fugl-Meyer Assessment for upper limbs less than or equal to 50;
(6) ability to sit and continuously exercise their upper limbs for over 30 minutes.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) open wounds around the hand and wrist or patients with infectious skin disease;
(2) shoulder joint or other orthopedic diseases and cannot exercise upper limbs;
(3) serious heart disease, such as angina pectoris;
(4) reflex sympathetic dystrophy were excluded.

Study design
Purpose of the study
Prevention
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
Descriptive statistics were used to describe the demographic data.
Paired-t tests were used to compare the differences in skin temperature in the patients’ affected and unaffected hands during and after their use of the exercise equipment, with Yole hands and with elastic bandages.
All data were analyzed using SPSS, version 22, at an alpha level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/10/2015
Date of last participant enrolment
Anticipated
Actual
31/01/2016
Date of last data collection
Anticipated
Actual
31/01/2016
Sample size
Target
30
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 8410 0
Taiwan, Province Of China
State/province [1] 8410 0
Kaohsiung

Funding & Sponsors
Funding source category [1] 295040 0
University
Name [1] 295040 0
Fooyin University
Country [1] 295040 0
Taiwan, Province Of China
Primary sponsor type
University
Name
Fooyin University
Address
No.151 Jinxue Rd., Daliao Dist., Kaohsiung City 83102, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 293857 0
Hospital
Name [1] 293857 0
Kaohsiung Chang Gung Memorial Hospital
Address [1] 293857 0
No.123, Dapi Rd., Niaosong Dist., Kaohsiung City 833, Taiwan (R.O.C.)
Country [1] 293857 0
Taiwan, Province Of China
Secondary sponsor category [2] 293858 0
University
Name [2] 293858 0
National Yang-Ming University
Address [2] 293858 0
No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112, Taiwan (R.O.C.)
Country [2] 293858 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296397 0
Institutional Review Board of Kaohsiung Chang Gung Memorial Hospital
Ethics committee address [1] 296397 0
No.123, Dapi Rd., Niaosong Dist., Kaohsiung City 833, Taiwan (R.O.C.)
Ethics committee country [1] 296397 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296397 0
09/07/2015
Approval date [1] 296397 0
05/08/2015
Ethics approval number [1] 296397 0
104-1325B

Summary
Brief summary
Background and Purpose:
Elastic bandages are often used to secure stroke patients’ affected upper limbs to exercise equipment during physical rehabilitation. Application of elastic bandages can hamper blood circulation in the patients’ extremities, as indicated by a drop in the skin temperatures of the patients’ hands. Our research team developed the novel medical hand gloves —“Yole hands”. Yole hands safely secure stroke patients’ affected hands to their exercise equipment with even pressure on both sides of the hands in order to maintain peripheral blood circulation of upper limbs and achieve rehab benefits. However, Yole hands is a newly developed assistive device without historical data to quantify its benefits. The purpose of this study was to compare Yole hands and traditional elastic bandages as measured by changes in body temperature during the stroke patients’ use of upper body rehabilitation equipment.
Methods:
Eighteen stroke patients (male/female: 10/8) with an average age of 63.1 (+/-13.4) years were recruited from a rehab clinic in the south of Taiwan. The use of either Yole hands or elastic bandage on the patient’s affected hand were decided in random order. Another physical therapist, other than the primary investigator recording the patient’s hand temperature, secured the patient’s affected hand onto one arm of the exercise equipment, while the patient’s unaffected hand gripped the other arm of the exercise equipment unaided. In the initial test,the movement of the patients’ upper limbs were limited to 120 degrees(+/-10 degrees) shoulder angle and 100 degrees (+/-10 degrees) elbow angle, at a movement frequency of 4 cycles every 10 seconds and a duration of 15 minutes. The patient’s hand temperature was recorded throughout the entire exercise and 5 minutes after completing the exercise. After the initial test, the patient was allowed to rest for a day before conducting the second test. If Yole hands was used in the initial test, then elastic bandage was used to secure the patient’s affected hand to the exercise equipment in the second test. Paired-t tests were used to compare the differences in skin temperature in the patients’ affected and unaffected hands during and after their use of the exercise equipment, with Yole hands and with elastic bandages.
Conclusions:
With the use of Yole hands, the temperature changes of the patients’ affected hands during and after the 15-minute exercise closely mirrored those of their unaffected hands. After resting for five minutes after completing their exercise, the temperature of the patients’ affected hands were able to return to their initial baselines, and some even slightly higher. This demonstrates that the use of Yole hands did not impede blood flow in stroke patients’ limbs and allowed the patients to achieve increased blood circulation during passive exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70722 0
Mr Chan-Yu Taso
Address 70722 0
Departments and Institutions: Department of Physical Therapy, Kaohsiung Chang Gung Memorial Hospital
No.123, Dapi Rd., Niaosong Dist., Kaohsiung City 833, Taiwan (R.O.C.)
Country 70722 0
Taiwan, Province Of China
Phone 70722 0
+886-7-7317123
Fax 70722 0
+886-7-7317123
Email 70722 0
playashulo@gmail.com
Contact person for public queries
Name 70723 0
A/Prof Shu-Shi Chen
Address 70723 0
Departments and Institutions: Department of Physical Therapy, School of Medical and Health Sciences, Fooyin University
No.151 Jinxue Rd., Daliao Dist., Kaohsiung City 83102, Taiwan (R.O.C.)
Country 70723 0
Taiwan, Province Of China
Phone 70723 0
+886 7-781-1151 ext. 5470
Fax 70723 0
+886 7-786-2513
Email 70723 0
sc1861@hotmail.com
Contact person for scientific queries
Name 70724 0
A/Prof Shu-Shi Chen
Address 70724 0
Departments and Institutions: Department of Physical Therapy, School of Medical and Health Sciences, Fooyin University
No.151 Jinxue Rd., Daliao Dist., Kaohsiung City 83102, Taiwan (R.O.C.)
Country 70724 0
Taiwan, Province Of China
Phone 70724 0
+886 7-781-1151 ext. 5470
Fax 70724 0
+886 7-786-2513
Email 70724 0
sc1861@hotmail.com

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