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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stroke

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

Ischaemic

Stroke

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]

Rehabilitation

Intervention code [2]

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]

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]

The subject’s hand temperature was recorded throughout the entire exercise, before exercise and 5 minutes after completing the exercise.

Secondary outcome [1]

none

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Kaohsiung

Funding & Sponsors

Funding source category [1]

University

Name [1]

Fooyin University

Address [1]

No.151 Jinxue Rd., Daliao Dist., Kaohsiung City 83102, Taiwan (R.O.C.)

Country [1]

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]

Hospital

Name [1]

Kaohsiung Chang Gung Memorial Hospital

Address [1]

No.123, Dapi Rd., Niaosong Dist., Kaohsiung City 833, Taiwan (R.O.C.)

Country [1]

Taiwan, Province Of China

Secondary sponsor category [2]

University

Name [2]

National Yang-Ming University

Address [2]

No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112, Taiwan (R.O.C.)

Country [2]

Taiwan, Province Of China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Board of Kaohsiung Chang Gung Memorial Hospital

Ethics committee address [1]

No.123, Dapi Rd., Niaosong Dist., Kaohsiung City 833, Taiwan (R.O.C.)

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

09/07/2015

Approval date [1]

05/08/2015

Ethics approval number [1]

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

Mr Chan-Yu Taso

Address

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

Taiwan, Province Of China

Phone

+886-7-7317123

Fax

+886-7-7317123

playashulo@gmail.com

Contact person for public queries

Name

Shu-Shi Chen

Address

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

Taiwan, Province Of China

Phone

+886 7-781-1151 ext. 5470

Fax

+886 7-786-2513

sc1861@hotmail.com

Contact person for scientific queries

Name

Shu-Shi Chen

Address

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

Taiwan, Province Of China

Phone

+886 7-781-1151 ext. 5470

Fax

+886 7-786-2513

sc1861@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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