Effects of different dynamic sitting strategies in wheelchair seating

ISRCTN	ISRCTN12389808
DOI	https://doi.org/10.1186/ISRCTN12389808
Secondary identifying numbers	A-ER-103-375

Submission date: 12/11/2016
Registration date: 18/11/2016
Last edited: 20/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims:
For people who are wheelchair bound, lower back pain and pressure ulcers (wounds caused when area of skin is placed under pressure) are a big concern. The way a person sits in the wheelchair, including the position of the buttocks and weight put on the spine has an important role in the development of these problems. The aim of this study is to investigate the effects of different sitting positions on back angles and skin pressure in order to see if there is a way to reduce the risk of lower back pain and pressure ulcers in wheelchair-bound people.

Who can participate?
Healthy adult male or female volunteers aged between 20 and 65 years.

What does the study involve?
The participants perform of the seven different sitting positions in random order by drawing lots. Each test lasts for 20 minutes, with periodic changes at 5-minute intervals. The participants are asked to stand up and move around for 5 minutes between each test. Over each 20 minute test, participants have the angle of their spine and pressure on their skin measured.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
Applied Biomechanics Laboratory, National University of Tainan (Taiwan)

When is the study starting and how long is it expected to run for?
March 2015 to November 2015

Who is funding the study?
Ministry of Science and Technology (Taiwan)

Who is the main contact?
Professor Kuen-Horng Tsai
tsaikh@mail.nutn.edu.tw

Contact information

Prof Kuen-Horng Tsai
Scientific

Graduate Institute of Mechatronic System Engineering
National University of Tainan
No. 33, Section 2
Shu-Lin Street
West Central District
Tainan City
70005
Taiwan

ORCID ID	0000-0002-4360-3712
Phone	+886 (0)6 260 6123
Email	tsaikh@mail.nutn.edu.tw

Study information

Study design	Single-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	No participant information sheet available
Scientific title	Biomechanical effects of different dynamic sitting strategies in wheelchair seating
Study objectives	Lumbar-pelvic angle and interface pressure are influenced by different dynamic sitting strategies.
Ethics approval(s)	Institutional Review Board of National Cheng Kung University Hospital, 13/03/2015, ref: A-ER-103-375
Health condition(s) or problem(s) studied	Lower back pain and pressure ulcers
Intervention	The initial settings for the experimental wheelchair forms a 100° angle between the backrest and seat cushion, and a 120° angle between the seat cushion and footrest. The seat cushion is adjusted to allow a gap between the cushion and popliteal fossa. When the participants are seated in the experimental wheelchair, they are asked to rest their upper body against the backrest, relax their arms and place them at their sides, try to keep their thighs parallel to the ground, place their feet firmly on top of the footrest at shoulder width, and look directly ahead. Next, they perform each of the 7 DSSs in random order by drawing lots: 1. Lumbar prominent dynamic sitting (LPDS): The lumbar adjustment module is positioned at L3 of participant, and the air bag provides dynamic adjustment by deflating to 0 cm and inflating to 4 cm at periodic intervals. 2. Back reclined dynamic sitting (BRDS): Upper body contact is maintained with the backrest in the experimental wheelchair, and the backrest tilt mechanism provides dynamic adjustment by tilting backward and forward between 100° and 150° at periodic intervals. 3. Femur upward dynamic sitting (FUDS): The femur adjustment module is positioned at the midpoint of the participant’s femur, and the air bag provides dynamic adjustment by deflating to 0 cm and inflating to 4 cm at periodic intervals. 4. Lumbar prominent with back reclined dynamic sitting (LBDS): This combines the LPDS and BRDS settings. 5. Lumbar prominent with femur upward dynamic sitting (LFDS): This combines the LPDS and FUDS settings. 6. Back reclined with femur upward dynamic sitting (BFDS): This combines the BRDS and FUDS settings. 7. Lumbar prominent with back reclined with femur upward dynamic sitting (LBFDS): This combines the LPDS, BRDS, and FUDS settings. Each DSS test lasts for 20 minutes, with periodic changes at 5-minute intervals. The participants are asked to stand up and move around for 5 minutes between each DSS test. Data on lumbar-pelvic angle were collected by the ultrasound-based motion analysis system (CMS20S Measuring System; zebris Medical GmbH, Isny im Allgäu, Germany), and the data on interface pressure were collected by the pressure-mapping mats (Body Pressure Measurement System; Tekscan Inc, South Boston, Massachusetts, USA).
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Lumbar-pelvic angle is measured using the ultrasound-based motion analysis system over the 20 minutes of each DDS
Secondary outcome measures	Interface pressure is measured using the pressure-mapping mats over the 20 minutes of each DDS
Overall study start date	13/03/2015
Completion date	30/11/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Age 20-65 years 2. Able-bodied
Key exclusion criteria	1. Spinal pathology 2. Musculoskeletal disorder 3. Those who have sought medical treatment for lumbar pain within the previous 6 months
Date of first enrolment	11/05/2015
Date of final enrolment	15/07/2015

Locations

Countries of recruitment

Taiwan

Study participating centre

National University of Tainan

Applied Biomechanics Laboratory
Graduate Institute of Mechatronic System Engineering
No. 33, Sec. 2
Shu-Lin St.
West Central Dist.
Tainan City
70005
Taiwan

Sponsor information

Ministry of Science and Technology, Taiwan
Government

No. 106, Sec. 2
He-Ping E. Road
Taipei City
10622
Taiwan

Phone	+886 (0)2 2737 7992
Email	misservice@most.gov.tw
Website	https://www.most.gov.tw/
"ROR"	https://ror.org/02kv4zf79

Funders

Funder type

Government

Ministry of Science and Technology, Taiwan
Government organisation / National government

Alternative name(s): Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
Location: Taiwan

Results and Publications

Intention to publish date	30/11/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/12/2016		Yes	No

Editorial Notes

20/10/2017: Publication reference added.