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Treadmill Training With Thera-Band in Stroke Patients

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07346352
Enrollment
40
Registered
2026-01-16
Start date
2019-01-01
Completion date
2020-01-30
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Patients

Keywords

stroke, rehabilitation, balance, mobility, depression, treadmill, Thera-Band

Brief 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). 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

Interventions

OTHERConventional therapy

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

OTHERtreadmill training

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.

OTHERThera-band

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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. being 18 years of age or older, 2. being diagnosed with stroke for the first time, 3. being able to walk 10 meters independently, 4. having lower extremity spasticity below 3 according to the modified Ashword scale (MAS), 5. being between stages 3-4 according to Brunnstrom, 6. having a score of 22 or above on the mini mental test

Exclusion criteria

1. high blood pressure, heart disease, 2. agnosia or visual impairment, 3. limitation of joint movement in the lower extremity on the hemiplegic side, 4. any botulinum toxin application or surgical operation in the last 6 months

Design outcomes

Primary

MeasureTime frameDescription
Mobility8 weekAssessed 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
Balance8 weekAssessed 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)8 weekAssessed 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.

Secondary

MeasureTime frameDescription
Lower Extremity Spasticity8 weekAssessed 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.
Depression8 weekAssessed 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026