Effects of Backward vs Forward Gait Training With Auditory Feedback in Patients With Stroke

Stroke, Ischemic Clinical Trial

Official title:

Effects of Backward vs Forward Gait Training With Auditory Feedback in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904860
• Other study ID #: IRB 0350-22
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: June 2023
• Source: Shifa Tameer-e-Millat University
• Contact: Manan Haider, PhD
• Phone: +923334839810
• Email: m_manan.drs[@]stmu.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the major expressions of chronic disability in patients with cerebrovascular accidents is in terms of impaired gait and balance. Both of these limitations have an ultimate effect in terms of increased risk of falls leading to augmented morbidity and mortality. Further results of gait abnormalities and balance impairments are increased morbidity with many other manifestations including but not limited to; pain, a significant reduction in quality of life, muscle as well as joint stiffness, postural instability self-imposed restricted physical functioning, and limited social interaction. The chances of an acute recurrent stroke are substantially increased due to restricted mobility.

Description:

A variety of treatment options are available for balance improvement and gait training in stroke patients including conventional treatment options of stretching, muscle strengthening, limb stabilization joint mobilizations followed by forward walking training with or without support and modern technological advancements including virtual reality immersion exercises, motor imagery and hydro treadmill. However, backward walking, also known as retro gait, is the emerging key therapy for gait training. Neuronal circuits located inside the spinal cord and brainstem; known as central pattern generators (CPGs), are primarily responsible for producing automated outputs for rhythmic motor responses example ambulation. These CPGs, along with the descending system, are responsible for motor neuron activation by setting the threshold muscle lengths. The CPGs that are responsible for forward ambulation, also regulate the backward gait. A more intensified recruitment of lower limb musculature motor unit has been observed during backward gait in individuals. Also, due to the restricted visual field when walking backward, the temporal and spatial gait parameters are significantly increased. For the aforementioned reasons, backward gait training can be used as an alternative strategy to improve balance and ambulation.

The performance of an individual during motor relearning can be influenced by using a stimulus from an external source that will generate a behavioral response leading to self-modification in motor action known as a biofeedback system. The most common types of biofeedback include visual, auditory as well as tactile stimuli that inform the individual involved in biofeedback training, about his relative achievements in reaching gait and balance-related targets. Recent literature proposes the notion that in a comparison of visual biofeedback versus auditory biofeedback, individuals under study are more prone to develop a dependence on external cues when using visual biofeedback. Also, poor performance was demonstrated by individuals receiving training with visual feedback on motor retention tests as compared to the individuals receiving auditory feedback. Thus auditory feedback tends to be more helpful in terms of motor relearning.

Backward walking training activates the central pattern generators that are responsible for ambulation however, muscle fiber recruitment had been observed to be more intensified as compared to recruitment during forward gait training. Forward gait training with auditory biofeedback effectively improves stride length, balance, and walking speed in individuals with stroke.

Since backward gait training has a more pronounced effect on gait parameters as compared to forward walking, also, in the light of recent evidence motor re-learning can be enhanced using biofeedback, the combined effect of backward gait training with auditory biofeedback could produce more pronounced effects in terms of motor recovery and improved balance and decreased risk of fall as compared to conventional forward gait training with biofeedback.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 25, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

Both genders First-time ischemic stroke Diagnosed Middle cerebral artery stroke patients Sub-acute stroke 3 weeks- 11 weeks Hemiplegia Age 35 years to 65 years Brunnstorm's stages 4 to 6 Able to maintain standing posture with minimum assistance with a Berg balance scale score greater than 45

Exclusion Criteria:

GCS lower than 15 Any other neurological diagnosis Presence of associated cognitive impairment Lower extremity joint deformities Any prominent visual problem hindering ambulation Patients with auditory compromise and patients using hearing aids

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• Backward Gait Training
Backward gait training will be provided within parallel bars, a mirror, and on a firm surface. The harness belt will be around the patient's torso to avoid sudden falls.
• Forward Gait Training
Forward gait training will be provided within parallel bars, a mirror, and on a firm surface. The harness belt will be around the patient's torso to avoid sudden falls.

Locations

Country	Name	City	State
Pakistan	Shifa Tameer-e-Millat University Islamabad	Islamabad	Fedral

Sponsors (1)

Lead Sponsor	Collaborator
Shifa Tameer-e-Millat University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

Balasukumaran T, Olivier B, Ntsiea MV. The effectiveness of backward walking as a treatment for people with gait impairments: a systematic review and meta-analysis. Clin Rehabil. 2019 Feb;33(2):171-182. doi: 10.1177/0269215518801430. Epub 2018 Sep 19. — View Citation

Bytyci I, Henein MY. Stride Length Predicts Adverse Clinical Events in Older Adults: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jun 17;10(12):2670. doi: 10.3390/jcm10122670. — View Citation

Cha YJ, Kim JD, Choi YR, Kim NH, Son SM. Effects of gait training with auditory feedback on walking and balancing ability in adults after hemiplegic stroke: a preliminary, randomized, controlled study. Int J Rehabil Res. 2018 Sep;41(3):239-243. doi: 10.1097/MRR.0000000000000295. — View Citation

Feldman AG, Levin MF, Garofolini A, Piscitelli D, Zhang L. Central pattern generator and human locomotion in the context of referent control of motor actions. Clin Neurophysiol. 2021 Nov;132(11):2870-2889. doi: 10.1016/j.clinph.2021.08.016. Epub 2021 Sep 27. — View Citation

Kondo K, Noonan KM, Freeman M, Ayers C, Morasco BJ, Kansagara D. Efficacy of Biofeedback for Medical Conditions: an Evidence Map. J Gen Intern Med. 2019 Dec;34(12):2883-2893. doi: 10.1007/s11606-019-05215-z. Epub 2019 Aug 14. — View Citation

Maier M, Ballester BR, Verschure PFMJ. Principles of Neurorehabilitation After Stroke Based on Motor Learning and Brain Plasticity Mechanisms. Front Syst Neurosci. 2019 Dec 17;13:74. doi: 10.3389/fnsys.2019.00074. eCollection 2019. — View Citation

McLellan AG, Slaght J, Craig CM, Mayo A, Senechal M, Bouchard DR. Can older adults improve the identification of moderate intensity using walking cadence? Aging Clin Exp Res. 2018 Jan;30(1):89-92. doi: 10.1007/s40520-017-0746-3. Epub 2017 Apr 4. — View Citation

Park C, Oh-Park M, Dohle C, Bialek A, Friel K, Edwards D, Krebs HI, You JSH. Effects of innovative hip-knee-ankle interlimb coordinated robot training on ambulation, cardiopulmonary function, depression, and fall confidence in acute hemiplegia. NeuroRehabilitation. 2020;46(4):577-587. doi: 10.3233/NRE-203086. — View Citation

Ronsse R, Puttemans V, Coxon JP, Goble DJ, Wagemans J, Wenderoth N, Swinnen SP. Motor learning with augmented feedback: modality-dependent behavioral and neural consequences. Cereb Cortex. 2011 Jun;21(6):1283-94. doi: 10.1093/cercor/bhq209. Epub 2010 Oct 28. — View Citation

Rose DK, DeMark L, Fox EJ, Clark DJ, Wludyka P. A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. J Neurol Phys Ther. 2018 Jan;42(1):12-21. doi: 10.1097/NPT.0000000000000210. — View Citation

Spencer J, Wolf SL, Kesar TM. Biofeedback for Post-stroke Gait Retraining: A Review of Current Evidence and Future Research Directions in the Context of Emerging Technologies. Front Neurol. 2021 Mar 30;12:637199. doi: 10.3389/fneur.2021.637199. eCollection 2021. — View Citation

Steuer I, Guertin PA. Central pattern generators in the brainstem and spinal cord: an overview of basic principles, similarities and differences. Rev Neurosci. 2019 Jan 28;30(2):107-164. doi: 10.1515/revneuro-2017-0102. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	It is a 14 items static and dynamic balance measurement tool. The total score on this scale is 56 with 4 maximum scores in each item. Higher scores demonstrate good balance. Lower scores demonstrate poor balance.	4 weeks
Primary	Cadence	Pedometers are designed to detect vertical movement at the hip and so measure the number of steps and provide an estimate of the distance walked. They cannot provide information on the temporal pattern of physical activity or the time spent in different activities at different intensities.	4 weeks
Primary	Walking Speed	walking speed that would be calculated using formula "Walking speed = distance covered / time taken	4 weeks
Primary	Stride Length	stride length that would be calculated using formula "Stride length = Distance covered / (1/2x cadence)	4 weeks
Primary	Step Length	step length that would be calculated using formula "Step length = stride length / 2	4 weeks