Chronic StrokeNCT04974840
Thera-band Resisted Treadmill Training for Chronic Stroke Patients
A study testing Treadmill training combined with/ without thera-band in people with Chronic Stroke, run by Sang-I Lin at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Treadmill training combined with/ without thera-band
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the diagnosis of first time unilateral stroke more than 6 months before
- the ability to walk for at least 15 m without person assistance
- apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed < 0.8 m/s
- resting blood pressure lower than 150/90 mmHg.
Who cannot join
- older than 75 years
- inability to follow the experimental instructions or procedures
- any pain, inflammation, or other conditions that could affect walking
- medically unstable.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University
Tainan, 701
Sang-I Lin, PhD, +886-6-235-3535 ext. 5020, lin31@mail.ncku.edu.tw
About this study
Official title: Effects of Thera-band Resisted Treadmill Training on Walking Ability in Chronic Stroke Patients
The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.
Read the detailed description
This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.
- Conditions
- Chronic Stroke
- Being tested
- Treadmill training combined with/ without thera-band
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill training combined with/ without thera-bandBehavioural
Treadmill walking training with thera-band Treadmill walking training without thera-band
| Study group | Role | What they receive |
|---|---|---|
| Treadmill training combined with thera-band | Experimental | Participants will receive walking training on treadmill with thera-band at the waist. The direction of the thera-band resistance will be straight backward, backward-toward-right, and backward-toward-left. For each direction, the level of resistance and treadmill speed will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. Receives: Behavioral: Treadmill training combined with/ without thera-band |
| Treadmill training alone | Active comparator | Participants will receive treadmill walking training at a speed that will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. For each session, there will be three 10-min treadmill walking bouts. Receives: Behavioral: Treadmill training combined with/ without thera-band |
What is being measured
The primary outcome is the main question the study is designed to answer.
stride characteristics
Wearable movement sensors will be used to measure walking speed, stride length and time, and gait cycle.
Ground reaction forces during walking. A force platform will be used to measure ground reaction forces and center of pressure.
Measured: 8 weeks
Walking oxygen uptake
A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.
Measured: 8 weeks
Balance
Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Sep 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sang-I Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sang-I Lin, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974840
- Sponsor's protocol ID
- A-ER-110-027
- Status last verified
- Apr 2022
- First submitted
- 16 Jul 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thera-band Resisted Treadmill Training on Walking Ability in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT04974840
- Acronym / sponsor ID
- A-ER-110-027
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sang-I LinUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.
Detailed description
This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill training combined with thera-band | Experimental | Behavioral: Treadmill training combined with/ without thera-bandParticipants will receive walking training on treadmill with thera-band at the waist. The direction of the thera-band resistance will be straight backward, backward-toward-right, and backward-toward-left. For each direction, the level of resistance and treadmill speed will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. |
| Treadmill training alone | Active comparator | Behavioral: Treadmill training combined with/ without thera-bandParticipants will receive treadmill walking training at a speed that will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. For each session, there will be three 10-min treadmill walking bouts. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the diagnosis of first time unilateral stroke more than 6 months before
- the ability to walk for at least 15 m without person assistance
- apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed < 0.8 m/s
- resting blood pressure lower than 150/90 mmHg.
Key exclusion criteria (4 listed)
- older than 75 years
- inability to follow the experimental instructions or procedures
- any pain, inflammation, or other conditions that could affect walking
- medically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill training combined with/ without thera-bandTreadmill walking training with thera-band Treadmill walking training without thera-band | Behavioural | Treadmill training alone, Treadmill training combined with thera-band |
Primary outcome
stride characteristics
Time frame: 8 weeks
Wearable movement sensors will be used to measure walking speed, stride length and time, and gait cycle. Ground reaction forces during walking. A force platform will be used to measure ground reaction forces and center of pressure.
Walking oxygen uptake
Time frame: 8 weeks
A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.
Balance
Time frame: 8 weeks
Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training combined with/ without thera-band in people with Chronic Stroke, run by Sang-I Lin at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-I Lin (886-6-2757575 ext. 5020, lin31@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stride characteristics (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.