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

Sponsor
Shifa Tameer-e-Millat University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05904860
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
1.6
Anticipated Duration (Months)
27.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Backward Gait Training
  • Other: Forward Gait Training
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (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.
Primary Purpose:
Treatment
Official Title:
Effects of Backward vs Forward Gait Training With Auditory Feedback in Patients With Stroke
Actual Study Start Date :
Jun 6, 2023
Anticipated Primary Completion Date :
Jul 11, 2023
Anticipated Study Completion Date :
Jul 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Experimental Group

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
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.
Other Names:
  • Auditory Feedback

    		•
    Other: Control group

    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
    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.
    Other Names:
  • Auditory Feedback

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Berg Balance Scale [4 weeks]

      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.

    2. Cadence [4 weeks]

      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.

    3. Walking Speed [4 weeks]

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

    4. Stride Length [4 weeks]

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

    5. Step Length [4 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shifa Tameer-e-Millat University Islamabad Islamabad Fedral Pakistan 44000

    Sponsors and Collaborators

    • Shifa Tameer-e-Millat University

    Investigators

    • Principal Investigator: Noor-ul-ain Sohail, MS-PT*, Shifa Tameer-e-Millat University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nouman Khan, Lecturer, Shifa Tameer-e-Millat University
    ClinicalTrials.gov Identifier:
    NCT05904860
    Other Study ID Numbers:
    • IRB 0350-22
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nouman Khan, Lecturer, Shifa Tameer-e-Millat University
    Stroke, Gait Training, Auditory feedback
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Jun 15, 2023