The use of sling exercise therapy for weakness and functional disability on one side of the body after a stroke
| ISRCTN | ISRCTN94005673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94005673 |
- Submission date
- 13/05/2022
- Registration date
- 27/05/2022
- Last edited
- 26/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Stroke patients have problems with trunk control, which is linked with restricted balance, an increased risk of falls, poor walking performance, and dependence on people in daily activities. The goal of physical therapy is to improve the trunk stability of stroke patients. In addition, recent studies have found that trunk exercises performed on an unstable surface are more effective than those performed on a stable surface. Sling exercise therapy (SET), one of the common unstable surfaces, can help patients perform the training program more effectively by supporting their body weight with an elastic cord. The aim of this study is to determine the effects of core stability exercises using sling exercise training on balance, walking, and activities of daily living for patients with subacute hemiparesis (weakness of one side of the body).
Who can participate?
Patients diagnosed with their first stroke with hemiplegia within the last 6 months who can walk independently
What does the study involve?
Participants are randomly allocated to the sling exercise training or conventional physical therapy. Participants receive the training for 8 weeks and their trunk function, balance, walking and daily living activities are assessed before and after 8 weeks of training.
What are the possible benefits and risks of participating?
Balance, walking and daily living activities may be improved after the training, and trunk function may be improved after the sling exercise intervention.
Where is the study run from?
Yuan’s General Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
October 2017 to March 2018
Who is funding the study?
1. Ministry of Science and Technology (Taiwan)
2. National Sun Yat-sen University (Taiwan)
3. Kaohsiung Medical University (Taiwan)
Who is the main contact?
Miss Shih-Chi Tseng
origin0725@gmail.com
Contact information
Scientific
No.100
Shih-Chuan 1st Road
Sanmin Dist
Kaohsiung
807
Taiwan
| Phone | +886 (0)7 312 1101#2646#624 |
|---|---|
| origin0725@imst.nsysu.edu.tw |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available |
| Scientific title | The effect of core stability exercises using sling exercise therapy on trunk function, balance ability, walking performance and daily living activities in subacute hemiparesis patients |
| Study hypothesis | The sling exercise training improved balance ability, walking performance and activities of daily living significantly compared to baseline measurement and the conventional therapy intervention. |
| Ethics approval(s) | Approved 25/12/2017, Institutional Review Board of Yuan’s General Hospital (No. 162, Chenggong 1st Road, Lingya Dist., Kaohsiung City, Taiwan (R.O.C.); +886 (0)7 3350205; irb@yuanhosp.com.tw), ref: 20171031B |
| Condition | Subacute stroke |
| Intervention | Participants were randomly assigned to study groups by sealed envelopes to receive sling exercise training for the experiment group and conventional physical therapy for the control group. All participants receive a total of 20 intervention sessions, 3 intervention sessions a week and 1 hour per session, over 8 weeks. |
| Intervention type | Other |
| Primary outcome measure | 1. Balance ability measured by Timed Up & Go, Berg Balance scale and postural assessment scale at baseline and post-intervention (8 weeks) 2. Walking performance measured by 5-meter walking test and 6-minute walking test at baseline and post-intervention (8 weeks) |
| Secondary outcome measures | 1. Trunk function measured by the Trunk Impairment Scale and the pelvic backward tilt force by using stabilizer pressure biofeedback at baseline and post-intervention (8 weeks) 2. Daily living activities measured by the Barthel index and the activities-specific balance confidence scale at the baseline and post-intervention (8 weeks) |
| Overall study start date | 30/10/2017 |
| Overall study end date | 12/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 56 |
| Total final enrolment | 40 |
| Participant inclusion criteria | 1. Less than 6 months since diagnosis of first stroke with hemiplegia 2. Modified Rankin Scale scores less than or equal to 4 (MRS ≤ 4) 3. Independent walking |
| Participant exclusion criteria | 1. Trunk Impairment Scale (TIS) score of 17 or more 2. Other musculoskeletal or neurologic problems |
| Recruitment start date | 25/12/2017 |
| Recruitment end date | 15/01/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
802
Taiwan
Sponsor information
University/education
No. 100, Shiquan 1st Rd, Sanmin Dist
Kaohsiung
807
Taiwan
| Phone | +886 (0)7 312 1101#2646#624 |
|---|---|
| yuen@kmu.edu.tw | |
| Website | http://english2.kmu.edu.tw/front/bin/home.phtml |
"ROR" |
https://ror.org/03gk81f96 |
Funders
Funder type
Government
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
Government organisation / Universities (academic only)
- Alternative name(s)
- NSYSU
- Location
- Taiwan
Private sector organisation / Universities (academic only)
- Alternative name(s)
- 高雄醫學大學-, Kaohsiung Medical University | Kaohsiung Medical University, Kaohsiung Medical University in Taiwan, Kaohsiung Medical University (KMU) - Taiwan, Kaohsiung Medical University, Taiwan, Kaohsiung Medical University | 台灣指南, Kaohsiung Medical College, KMU
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| 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 will be included in the subsequent results publication |
Editorial Notes
25/05/2022: Trial's existence confirmed by the Institutional Review Board of Yuan’s General Hospital.
