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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mobility
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
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.
干预措施: Conventional therapy (Other)
Control Group
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.
干预措施: treadmill training (Other)
Experimental Group
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.
干预措施: Conventional therapy (Other)
Experimental Group
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.
干预措施: treadmill training (Other)
Experimental Group
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.
干预措施: Thera-band (Other)
结局指标
主要结局
Mobility
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Lower Extremity Spasticity(8 week)
- Depression(8 week)
研究者
Duygu Korkem
Assistant Professor, PhD
Hacettepe University