The training effects of the pinnacle trainer and the elliptical trainer on walking ability and balance restoration in chronic stroke
| ISRCTN | ISRCTN27645313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27645313 |
- Submission date
- 15/06/2021
- Registration date
- 22/06/2021
- Last edited
- 14/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
A stroke happens when the blood supply to part of the brain is cut off. Balance deficits are a common problem after stroke. Pinnacle trainers (PT) are exercise trainers that involve major hip joint muscle effort, while elliptical trainers (ET) involve major effort on the shank muscles. The aim of this study is to investigate the training effects of PT and ET on the walking ability and balance of chronic stroke patients.
Who can participate?
Chronic stroke patients with hemiplegia (paralysis on one side of the body) in Taiwan
What does the study involve?
Participants are allocated into three groups to undergo an 8-week PT, ET or conventional therapy intervention. All participants are asked to perform walking tests and an obstacle crossing task at the start of the study and after the 8-week intervention.
What are the possible benefits and risks of participating?
The possible benefits are gait and balance improvements. The possible risks include falls during the obstacle crossing task, but during the measurements and intervention the therapist and research assistant are arranged around the participants to reduce the risk.
Where is the study run from?
National Cheng Kung University Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2016 to August 2018
Who is funding the study?
Ministry of Economic Affairs (Taiwan)
Who is the main contact?
Prof. Cheng-Feng Lin
connie@mail.ncku.edu.tw
Contact information
Scientific
Department of Physical Therapy
National Cheng Kung University
No.1, University Road
Tainan
701
Taiwan
 ORCID ID |
0000-0002-2466-0156 |
|---|---|
| Phone | +886 (6)2353535 ext. 5911 |
| connie@mail.ncku.edu.tw |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Clinical efficacy test for the pinnacle trainer integrated with an intelligent suspension system |
| Study objectives | Walking ability improves after the intervention and balance ability improves after the pinnacle trainer (PT) intervention compared to the baseline measurements. |
| Ethics approval(s) | Approved 21/01/2016, Institutional Review Board of National Cheng Kung University Hospital (138 Sheng-Li Rd, Tainan 704, Taiwan; +886 (6)2353535 ext. 3635; em73635@mail.hop.ncku.edu.tw), ref: B-ER-101-059 |
| Health condition(s) or problem(s) studied | Chronic stroke with unilateral hemiplegia |
| Intervention | Participants were allocated into three groups, namely the pinnacle trainer (PT) group, the elliptical trainer (ET) group and the control group (conventional therapy). The participants in the PT and ET groups undergo 8-week pinnacle and elliptical trainer interventions, respectively, in conjunction with conventional therapy. The intervention sessions take place three days a week for about 60 minutes per session. The participants exercise on either the PT or ET for 30 minutes under the guidance of an experienced therapist and receive conventional therapy on the same day for 30 minutes. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline (before intervention) and after 8 weeks (after completing the intervention): 1. Walking distance measured using the 6-minute walk test 2. Walking speed measured using the 10-meter walk test 3. Balance ability measured using obstacle crossing |
| Secondary outcome measures | Gait symmetry measured using a motion capture system at baseline (before intervention) and after 8 weeks (after completing the intervention) |
| Overall study start date | 21/01/2016 |
| Completion date | 13/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. Unilateral hemiplegia occurred after the first stroke 2. Onset time is at least 6 months prior to the study 3. A Brunnstrom stage of above 3 4. A Mini-Mental Status Examination (MMSE) score above 24 5. A functional ambulation category (FAC) score of at least 2 6. The ability to stand for at least 10 seconds with/without assistance |
| Key exclusion criteria | Bilateral hemiplegia occurred after the first stroke |
| Date of first enrolment | 13/05/2016 |
| Date of final enrolment | 14/06/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centres
Tainan
701
Taiwan
Tainan
704
Taiwan
Sponsor information
University/education
c/o Prof. Li-Chieh Kuo
Department of Occupational Therapy
College of Medicine
Tainan
70101
Taiwan
| Phone | +886 (6) 2353535 ext. 5949 |
|---|---|
| jkkuo@mail.ncku.edu.tw | |
| Website | https://www.ncku.edu.tw/ |
"ROR" |
https://ror.org/01b8kcc49 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Economic Affairs, R.O.C., MOEA
- Location
- Taiwan
Results and Publications
| Intention to publish date | 01/02/2022 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Basic results | 14/07/2021 | 14/07/2021 | No | No |
Additional files
- ISRCTN27645313_BasicResults_14Jul21.pdf
- Uploaded 14/07/2021
Editorial Notes
14/07/2021: The basic results of this trial have been uploaded as an additional file. The intention to publish date was changed from 01/07/2021 to 01/02/2022.
18/06/2021: Trial's existence confirmed by the Institutional Review Board of National Cheng Kung University Hospital.
