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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Kaohsiung Medical University |
| Funders | Ministry of Science and Technology, Taiwan, National Sun Yat-sen University, Kaohsiung Medical University |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized controlled trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. Balance ability measured by Timed Up & Go, Berg Balance scale and postural assessment scale at baseline and post-intervention (8 weeks) |
| Key secondary outcome measure(s) |
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) |
| Completion date | 12/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 56 |
| Total final enrolment | 40 |
| Key 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 |
| Key exclusion criteria | 1. Trunk Impairment Scale (TIS) score of 17 or more 2. Other musculoskeletal or neurologic problems |
| Date of first enrolment | 25/12/2017 |
| Date of final enrolment | 15/01/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
802
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/05/2022: Trial's existence confirmed by the Institutional Review Board of Yuan’s General Hospital.
