Clinical trial NCT04903392: Effects of Backward Gait Training in Chronic Stroke Patients
Official title: Investigation of the Effects of Gait Training on Balance, Plantar Pressure Distribution and Respiratory Parameters in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke Patients
Keywords: Chronic Stroke Patients
Balance
Plantar Pressure Distribution
Respiratory Parameters
Backward Gait Training
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Loss of motor control after stroke, muscle weakness, abnormal movement patterns, spasticity, range of motion limitations and sensory dysfunction, resulting in a decrease in the load transferred to the affected limb, changes in gait pattern and balance skills. Post-stroke muscle weakness has been shown to occur not only in the lower and upper extremity muscles but also in the respiratory muscles. It was found that the plantar pressure distribution in the affected side feet was decreased in individuals with stroke and this situation negatively affected the walking function. A systematic review of treadmill training revealed that treadmill training significantly increased walking speed and walking distance. Learning to walk backwards is also recommended to improve the movement components required for walking forward. As a result of the investigations, although there are studies about the effects of back-walking training on walking and balance function in chronic stroke patients, there is no study investigating the effects on plantar pressure distribution and respiratory parameters. Therefore, this study, which planned to investigate the effects of treadmill retching training on balance, plantar pressure distribution and respiratory parameters in chronic stroke patients, will contribute to the literature.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* More than 6 months have passed since the onset of stroke
* First time stroke diagnosis
* Being between the ages of 40-65
* Spasticity severity in lower extremity less than 3 according to Modified Ashworth Scale,
* Being medically stable
* Ability to walk 10 meters and above without assistance

Exclusion Criteria:

* Presence of other neurological or orthopedic diseases that affect standing and walking involving the lower limbs
* Uncontrollable Hypertension
* Having been diagnosed with any pulmonary disease
* Severe cardiac conditions
* Uncontrollable DM
* Lack of cooperation

Primary outcomes:
measure: Plantar pressure assessment
timeFrame: 6 weeks
measure: Balance assessment
timeFrame: 6 weeks
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: 6 weeks
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: 6 weeks
measure: Pulmonary function (FEV1 / FVC)
timeFrame: 6 weeks
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: 6 weeks
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: 6 weeks
measure: Respiratory Muscle Strength
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Burçin Akçay
Study officials:
References:
citation: Kim KH, Lee KB, Bae YH, Fong SSM, Lee SM. Effects of progressive backward body weight suppoted treadmill training on gait ability in chronic stroke patients: A randomized controlled trial. Technol Health Care. 2017 Oct 23;25(5):867-876. doi: 10.3233/THC-160720.
citation: Munari D, Serina A, Disaro J, Modenese A, Filippetti M, Gandolfi M, Smania N, Picelli A. Combined effects of backward treadmill training and botulinum toxin type A therapy on gait and balance in patients with chronic stroke: A pilot, single-blind, randomized controlled trial. NeuroRehabilitation. 2020;46(4):519-528. doi: 10.3233/NRE-203067.
citation: Nadeau S, Amblard B, Mesure S, Bourbonnais D. Head and trunk stabilization strategies during forward and backward walking in healthy adults. Gait Posture. 2003 Dec;18(3):134-42. doi: 10.1016/s0966-6362(02)00070-x.
citation: Weng CS, Wang J, Pan XY, Yu ZZ, Wang G, Gao LP, Huo CN. [Effectiveness of backward walking treadmill training in lower extremity function after stroke]. Zhonghua Yi Xue Za Zhi. 2006 Oct 10;86(37):2635-8. Chinese.
citation: Yang YR, Yen JG, Wang RY, Yen LL, Lieu FK. Gait outcomes after additional backward walking training in patients with stroke: a randomized controlled trial. Clin Rehabil. 2005 May;19(3):264-73. doi: 10.1191/0269215505cr860oa.