Stroke PatientsNCT07346352
Treadmill Training With Thera-Band in Stroke Patients
A study testing Conventional therapy, treadmill training and Thera-band in people with Stroke Patients, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Background: The aim of our study was to investigate the effects of treadmill training with Thera-Band on depression, mobility, balance, and gait in stroke patients. Methods: This single-blind randomized controlled trial included 40 patients with hemiparesis (53.57±4.3 years). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Conventional therapy, treadmill training and Thera-band
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being 18 years of age or older,
- being diagnosed with stroke for the first time,
- being able to walk 10 meters independently,
- having lower extremity spasticity below 3 according to the modified Ashword scale (MAS),
- being between stages 3-4 according to Brunnstrom,
- having a score of 22 or above on the mini mental test
Who cannot join
- high blood pressure, heart disease,
- agnosia or visual impairment,
- limitation of joint movement in the lower extremity on the hemiplegic side,
- any botulinum toxin application or surgical operation in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Special education and rehabilitation center
Istanbul
About this study
Official title: Investigation of the Effect of Treadmill Training With Thera-Band on Depression, Mobility, Balance, and Gait in Stroke Patients: A Randomized Controlled, Single Blinded Study
Background: The aim of our study was to investigate the effects of treadmill training with Thera-Band on depression, mobility, balance, and gait in stroke patients.
Methods: This single-blind randomized controlled trial included 40 patients with hemiparesis (53.57±4.3 years). After assessment, patients were randomly assigned in two groups as intervention (Treadmill training + Thera-Band) and controls (Treadmill training). Before the intervention, participants in both groups received 30 minutes of convansional therapy and 30 minute treadmill training three times a week for 8 weeks. Intervention group additionally received Thera Band on both lower extremities. Patients' mobility levels were assessed using the Rivermead Motor Assessment Index (RMD), balance using the Berg Balance Scale (BBS), lower extremity spasticity using the Modified Ashworth Scale (MAS), depression levels using the Back Depression Scale, and gait ability using the footprint method on powdered ground. Assessments were repeated before and after 8 weeks of treatment.
Key words: stroke, rehabilitation, balance, mobility, depression, treadmill, Thera-Band
- Conditions
- Stroke Patients
- Being tested
- Conventional therapy, treadmill training, Thera-band
- Keywords
- stroke, rehabilitation, balance, mobility, depression, treadmill, Thera-Band
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapyOther
Conventional therapy consisted of lower extremity weight-bearing and isolated joint exercises, bridge exercises, neuromuscular facilitation techniques, trunk rotation during reaching, standing training, spasticity-reducing exercises in sitting and lying positions, and activities of daily living training
treadmill trainingOther
Participants in each group were exercised on a Cateye EC-t220 model treadmill (Kuwazu, Higashi sumiyoshi-Ku, OSAKA, JAPAN) 3 days a week for 30 minutes each for 8 weeks. Every gait trial was conducted at the patient's chosen pace. Prior to the initial treadmill experiment, respondents were instructed to walk on the treadmill at a low belt speed (0.4 km/h 1) and increase the belt speed by 0.2 km/h 1 every 10 seconds until they reached their chosen gait speed without assistance. After around 30 seconds of maintaining this pace, the subjects were asked to reassess, and if required, the gait speed was changed. Until the patient's preferred walking speed was established, this procedure was repeated. Additionally, this procedure acted as a treadmill gait familiarization period. This acclimatization period was prolonged if needed until the participant reported having a comfortable gait while using the treadmill.
Thera-bandOther
In the intervention group, strengthening during treadmill training was provided using a green Thera-Band applied bilaterally to the lower extremities. The green Thera-Band was selected for all participants to standardize resistance, as it provides a moderate resistance of approximately 2 pounds at 25% elongation. The Thera-Band was wrapped around the distal foot, extended along the posterior aspect of the lower leg, passed behind the knee and in front of the thigh, and crossed over the dorsal surface of the ankle. This application aimed to support the lower limb during the swing phase and facilitate effective foot placement. Additionally, tactile stimulation along the lateral border of the foot was intended to facilitate dorsiflexion and eversion during gait.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants in the control group received conventional physical therapy and treadmill walking training three days per week for eight weeks. Conventional therapy consisted of lower extremity weight-bearing and isolated joint exercises, bridge exercises, neuromuscular facilitation techniques, trunk rotation during reaching activities, standing training, spasticity-reducing exercises in sitting and lying positions, and activities of daily living training. Treadmill training was performed for 30 minutes per session at the participant's preferred walking speed, following an individualized familiarization protocol. Receives: Other: Conventional therapy; Other: treadmill training |
| Experimental Group | Experimental | Participants in the experimental group received Thera-Band-assisted resistance walking during treadmill training in addition to the same conventional therapy and treadmill protocol as the control group. A green Thera-Band providing approximately 2 pounds of resistance at 25% elongation was used for all participants. The band was applied to support the lower extremity during the swing phase and to facilitate foot placement, dorsiflexion, and eversion through elastic resistance and tactile stimulation. Receives: Other: Conventional therapy; Other: treadmill training; Other: Thera-band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility
Assessed using the Rivermead Mobility Index (RMI). A tool for assessing mobility status, including fundamental mobility activities, is the Rivermead Mobility Index (RMI). One question is based on the test-giver's observations, while the other fourteen are answered by the patient's self-report. From turning in bed to running, the RMI evaluates a variety of activities. The total score is between 0-15. The higher the score, the higher the mobility level of the individual
Measured: 8 week
Balance
Assessed using the Berg Balance Scale (BBS). BBS is used to evaluate postural control and predict the risk of falls. The validity and reliability of the BBS has been demonstrated in both acute and chronic stroke patients. The 14 items on the BBS are scored on a total of 56 points, with 0-4 points awarded according on the patient's performance on each item. Impaired balance is indicated by 0-20 points, adequate balance is indicated by 21-40 points, and good balance is indicated by 41-56 points.
Measured: 8 week
Walking Ability (Gait Parameters)
Assessed using the Footprint Method on a 10-meter powdered walkway. With the footprint method, footprints were obtained by walking on a 10 m powdered floor at the speed of their choice. The steps in the middle 6 m area were analyzed by subtracting 2 m at the beginning and 2 m at the end. With this method, intact side stride length, hemiplegic side stride length, double stride length, gait tempo (steps/minute) were determined.
Measured: 8 week
Secondary outcomes (2)
Lower Extremity Spasticity
Assessed using the Modified Ashworth Scale (MAS). Spasticity was assessed using the Modified Ashworth Scale (MAS), a widely used clinical tool that measures resistance during passive soft-tissue stretching.
The scale grades muscle tone from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension), with higher scores indicating greater spasticity.
Measured: 8 week
Depression
Assessed using the Beck Depression Inventory (BDI). The Beck Depression Scale assesses depression's cognitive, emotional, and physical manifestations. There are twenty-one symptom categories on this self-assessment scale. 63 is the highest possible score. The severity of the depression increases with the total score. A score of 0-9 indicates little depression symptoms, 10-16 mild symptoms, 17-29 moderate symptoms, and 30-63 severe symptoms
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2019
- Primary completion15 Jun 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Korkem, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346352
- Sponsor's protocol ID
- B.08.6.YÖK.2.ÜS.0.05.0.06/2018
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Treadmill Training With Thera-Band on Depression, Mobility, Balance, and Gait in Stroke Patients: A Randomized Controlled, Single Blinded Study
- ClinicalTrials.gov ID
- NCT07346352
- Acronym / sponsor ID
- B.08.6.YÖK.2.ÜS.0.05.0.06/2018
- Conditions
- Stroke Patients
- Keywords
- stroke, rehabilitation, balance, mobility, depression, treadmill, Thera-Band
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 16 Jan 2026 (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.
Background: The aim of our study was to investigate the effects of treadmill training with Thera-Band on depression, mobility, balance, and gait in stroke patients.
Methods: This single-blind randomized controlled trial included 40 patients with hemiparesis (53.57±4.3 years). After assessment, patients were randomly assigned in two groups as intervention (Treadmill training + Thera-Band) and controls (Treadmill training). Before the intervention, participants in both groups received 30 minutes of convansional therapy and 30 minute treadmill training three times a week for 8 weeks. Intervention group additionally received Thera Band on both lower extremities. Patients' mobility levels were assessed using the Rivermead Motor Assessment Index (RMD), balance using the Berg Balance Scale (BBS), lower extremity spasticity using the Modified Ashworth Scale (MAS), depression levels using the Back Depression Scale, and gait ability using the footprint method on powdered ground. Assessments were repeated before and after 8 weeks of treatment.
Key words: stroke, rehabilitation, balance, mobility, depression, treadmill, Thera-Band
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional therapy, Other: treadmill trainingParticipants in the control group received conventional physical therapy and treadmill walking training three days per week for eight weeks. Conventional therapy consisted of lower extremity weight-bearing and isolated joint exercises, bridge exercises, neuromuscular facilitation techniques, trunk rotation during reaching activities, standing training, spasticity-reducing exercises in sitting and lying positions, and activities of daily living training. Treadmill training was performed for 30 minutes per session at the participant's preferred walking speed, following an individualized familiarization protocol. |
| Experimental Group | Experimental | Other: Conventional therapy, Other: treadmill training, Other: Thera-bandParticipants in the experimental group received Thera-Band-assisted resistance walking during treadmill training in addition to the same conventional therapy and treadmill protocol as the control group. A green Thera-Band providing approximately 2 pounds of resistance at 25% elongation was used for all participants. The band was applied to support the lower extremity during the swing phase and to facilitate foot placement, dorsiflexion, and eversion through elastic resistance and tactile stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being 18 years of age or older,
- being diagnosed with stroke for the first time,
- being able to walk 10 meters independently,
- having lower extremity spasticity below 3 according to the modified Ashword scale (MAS),
- being between stages 3-4 according to Brunnstrom,
Key exclusion criteria (4 listed)
- high blood pressure, heart disease,
- agnosia or visual impairment,
- limitation of joint movement in the lower extremity on the hemiplegic side,
- any botulinum toxin application or surgical operation in the last 6 months
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 |
|---|---|---|
| Conventional therapyConventional therapy consisted of lower extremity weight-bearing and isolated joint exercises, bridge exercises, neuromuscular facilitation techniques, trunk rotation during reaching, standing training, spasticity-reducing exercises in sitting and lying positions, and activities of daily living training | Other | Control Group, Experimental Group |
| treadmill trainingParticipants in each group were exercised on a Cateye EC-t220 model treadmill (Kuwazu, Higashi sumiyoshi-Ku, OSAKA, JAPAN) 3 days a week for 30 minutes each for 8 weeks. Every gait trial was conducted at the patient's chosen pace. Prior to the initial treadmill experiment, respondents were instructed to walk on the treadmill at a low belt speed (0.4 km/h 1) and increase the belt speed by 0.2 km/h 1 every 10 seconds until they reached their chosen gait speed without assistance. After around 30 seconds of maintaining this pace, the subjects were asked to reassess, and if required, the gait speed was changed. Until the patient's preferred walking speed was established, this procedure was repeated. Additionally, this procedure acted as a treadmill gait familiarization period. This acclimatization period was prolonged if needed until the participant reported having a comfortable gait while using the treadmill. | Other | Control Group, Experimental Group |
| Thera-bandIn the intervention group, strengthening during treadmill training was provided using a green Thera-Band applied bilaterally to the lower extremities. The green Thera-Band was selected for all participants to standardize resistance, as it provides a moderate resistance of approximately 2 pounds at 25% elongation. The Thera-Band was wrapped around the distal foot, extended along the posterior aspect of the lower leg, passed behind the knee and in front of the thigh, and crossed over the dorsal surface of the ankle. This application aimed to support the lower limb during the swing phase and facilitate effective foot placement. Additionally, tactile stimulation along the lateral border of the foot was intended to facilitate dorsiflexion and eversion during gait. | Other | Experimental Group |
Primary outcome
Mobility
Time frame: 8 week
Assessed using the Rivermead Mobility Index (RMI). A tool for assessing mobility status, including fundamental mobility activities, is the Rivermead Mobility Index (RMI). One question is based on the test-giver's observations, while the other fourteen are answered by the patient's self-report. From turning in bed to running, the RMI evaluates a variety of activities. The total score is between 0-15. The higher the score, the higher the mobility level of the individual
Balance
Time frame: 8 week
Assessed using the Berg Balance Scale (BBS). BBS is used to evaluate postural control and predict the risk of falls. The validity and reliability of the BBS has been demonstrated in both acute and chronic stroke patients. The 14 items on the BBS are scored on a total of 56 points, with 0-4 points awarded according on the patient's performance on each item. Impaired balance is indicated by 0-20 points, adequate balance is indicated by 21-40 points, and good balance is indicated by 41-56 points.
Walking Ability (Gait Parameters)
Time frame: 8 week
Assessed using the Footprint Method on a 10-meter powdered walkway. With the footprint method, footprints were obtained by walking on a 10 m powdered floor at the speed of their choice. The steps in the middle 6 m area were analyzed by subtracting 2 m at the beginning and 2 m at the end. With this method, intact side stride length, hemiplegic side stride length, double stride length, gait tempo (steps/minute) were determined.
2 secondary outcomes
Lower Extremity Spasticity
Time frame: 8 week
Depression
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapy, treadmill training and Thera-band in people with Stroke Patients, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 16 Jan 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility (time frame: 8 week). 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 16 Jan 2026.