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

NCT ID: NCT05904860

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2023-07-25

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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Backward Gait Training

Intervention Type: 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.

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.

Group Type: OTHER

Forward Gait Training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Auditory Feedback; Auditory Feedback

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shifa Tameer-e-Millat University

OTHER

Sponsor Role: lead

Responsible Party

Nouman Khan

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noor-ul-ain Sohail, MS-PT*

Role: PRINCIPAL_INVESTIGATOR

Shifa Tameer-e-Millat University

Locations

Shifa Tameer-e-Millat University Islamabad

Islamabad, Fedral, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Manan Haider, PhD

Role: CONTACT

m_manan.drs@stmu.edu.pk

+923334839810

Syed Ali Hussain, PhD*

Role: CONTACT

alihussain_dpt.ahs@stmu.edu.pk

+923315191713

Facility Contacts

Manan Haider, PhD

Role: primary

m_manan.drs@stmu.edu.pk

+923334839810

Syed Ali Hussain, PhD*

Role: backup

alihussain_dpt.ahs@stmu.edu.pk

+923315191713

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Other Identifiers

IRB 0350-22

Identifier Type: -

Identifier Source: org_study_id