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Completed

NCT Number: NCT07346352

Treadmill Training With Thera-Band in Stroke Patients

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

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Key information

Conditions

Stroke Patients Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Special education and rehabilitation center

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Conventional Therapy

Other

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 training

Other

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-band

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Lower Extremity Spasticity

    Time frame: 8 week

    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.

  2. Depression

    Time frame: 8 week

    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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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