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

Primary Purpose

Stroke, Ischemic

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Backward Gait Training
Forward Gait Training
Sponsored by
Shifa Tameer-e-Millat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Stroke, Gait Training, Auditory feedback

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shifa Tameer-e-Millat University IslamabadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Experimental Group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Walking Speed
walking speed that would be calculated using formula "Walking speed = distance covered / time taken
Stride Length
stride length that would be calculated using formula "Stride length = Distance covered / (1/2x cadence)
Step Length
step length that would be calculated using formula "Step length = stride length / 2

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
June 6, 2023
Sponsor
Shifa Tameer-e-Millat University
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1. Study Identification

Unique Protocol Identification Number
NCT05904860
Brief Title
Effects of Backward vs Forward Gait Training With Auditory Feedback in Patients With Stroke
Official Title
Effects of Backward vs Forward Gait Training With Auditory Feedback in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
July 11, 2023 (Anticipated)
Study Completion Date
July 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Tameer-e-Millat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Stroke, Gait Training, Auditory feedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Other
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Backward Gait Training
Other Intervention Name(s)
Auditory Feedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Forward Gait Training
Other Intervention Name(s)
Auditory Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
4 weeks
Title
Cadence
Description
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.
Time Frame
4 weeks
Title
Walking Speed
Description
walking speed that would be calculated using formula "Walking speed = distance covered / time taken
Time Frame
4 weeks
Title
Stride Length
Description
stride length that would be calculated using formula "Stride length = Distance covered / (1/2x cadence)
Time Frame
4 weeks
Title
Step Length
Description
step length that would be calculated using formula "Step length = stride length / 2
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manan Haider, PhD
Phone
+923334839810
Email
m_manan.drs@stmu.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Ali Hussain, PhD*
Phone
+923315191713
Email
alihussain_dpt.ahs@stmu.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noor-ul-ain Sohail, MS-PT*
Organizational Affiliation
Shifa Tameer-e-Millat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa Tameer-e-Millat University Islamabad
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manan Haider, PhD
Phone
+923334839810
Email
m_manan.drs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Syed Ali Hussain, PhD*
Phone
+923315191713
Email
alihussain_dpt.ahs@stmu.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30229667
Citation
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.
Results Reference
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PubMed Identifier
34204430
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.
Results Reference
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PubMed Identifier
29782407
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.
Results Reference
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PubMed Identifier
34628342
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.
Results Reference
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PubMed Identifier
31414354
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.
Results Reference
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PubMed Identifier
31920570
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.
Results Reference
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PubMed Identifier
28378230
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.
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
29232308
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.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Effects of Backward vs Forward Gait Training With Auditory Feedback in Patients With Stroke

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