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

NCT05904860 | Unknown

• 1 other identifier: IRB 0350-22
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Ischemic

Keywords

Stroke, Gait Training, Auditory feedback

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Walking Speed

  walking speed that would be calculated using formula "Walking speed = distance covered / time taken

  4 weeks

• Stride Length

  stride length that would be calculated using formula "Stride length = Distance covered / (1/2x cadence)

  4 weeks

• Step Length

  step length that would be calculated using formula "Step length = stride length / 2

  4 weeks

Study Arms (2)

Experimental Group

OTHER

The experimental group will be receiving a 30-minute backward gait training using parallel bars, a mirror, and on a firm surface. Patients will receive training for 4 days per week with a total time period of 4 weeks. Balance, fall risk, and spatiotemporal gait parameters will be quantified and evaluated before the commencement of treatment, after 2 weeks, and at the end of the last session.

Other: Backward Gait Training

Control group

OTHER

The control group will be receiving a 30-minute forward gait training using parallel bars, a mirror and on a firm surface. Patients will receive training for 4 days per week with a total time period of 4 weeks. Balance, fall risk, and spatiotemporal gait parameters will be quantified and evaluated before the commencement of treatment, after 2 weeks, and at the end of the last session.

Other: Forward Gait Training

Interventions

Backward Gait Training OTHER

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.

Also known as: Auditory Feedback

Experimental Group

Forward Gait Training OTHER

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.

Also known as: Auditory Feedback

Control group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shifa Tameer-e-Millat University: lead

Study Sites (1)

Shifa Tameer-e-Millat University Islamabad

Islamabad, Fedral, 44000, Pakistan

RECRUITING

Related 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.

  PMID: 30229667 BACKGROUND

• 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.

  PMID: 34204430 BACKGROUND

• 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.

  PMID: 29782407 BACKGROUND

• 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.

  PMID: 34628342 BACKGROUND

• 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.

  PMID: 31414354 BACKGROUND

• 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.

  PMID: 31920570 BACKGROUND

• 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.

  PMID: 28378230 BACKGROUND

• 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.

  PMID: 32538882 BACKGROUND

• 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.

  PMID: 21030486 BACKGROUND

• 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.

  PMID: 29232308 BACKGROUND

• 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.

  PMID: 33859607 BACKGROUND

• 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.

  PMID: 30543520 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Noor-ul-ain Sohail, MS-PT*

  Shifa Tameer-e-Millat University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manan Haider, PhD

CONTACT

+923334839810; m_manan.drs@stmu.edu.pk

Syed Ali Hussain, PhD*

CONTACT

+923315191713; alihussain_dpt.ahs@stmu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants of the study are not informed in which group they are placed. The placement of the group is selected through the sealed envelope method.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: total two groups are formed with 22 participants in each group. One is the treatment group which will receive backward gait training. The other is the control group receiving forward gait training. Pre-intervention outcomes are measured. Followed by mid-protocol outcome measurement after 2 weeks and end-protocol measurement after 4 weeks.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: June 6, 2023
• Primary Completion: July 11, 2023
• Study Completion: July 25, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)