Effects of Auditory and Visual Cueing on Sensorimotor Recovery and Gait in Hemiplegia

NCT06059781 | Unknown

• 1 other identifier: RiphahIU Sehrish Naureen
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is also known as a brain attack, happens when a blood vessel in the brain breaks or when something stops the flow of blood to a specific area of the brain. Parts of the brain undergo damage or die in either case. Stroke victims may experience permanent brain damage, long-term disability or even death. The main objective of this study is to evaluate the impact of combined auditory and visual rhythmical cueing on lower limb sensorimotor recovery and gait parameters in patients with hemiplegia. It will be a randomized controlled trial. In this study 28 patients will be recruited through non probability convenience sampling technique. The patients fulfilling inclusion and exclusion criteria will be randomly divided into experimental group (n=14) and control group (n=14) by using computer engendered in blocks by using a basic number generator. Distribution will be concealed by the sealed envelope method. Baseline treatment will be given to both groups. Baseline treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Conventional training will be given for 15 minutes, 3 sessions per week for 4 weeks. Experimental group (n=14) will be treated with auditory stimulation and visual cues. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks. The control group (n=14) will be treated with auditory stimulation only. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks. Subjective tool for sensory assessment includes Fugl-Meyer Assessment (FMA) for the lower extremity (LE) tool. For gait, it includes Dynamic Gait Index (DGI) tool. Objective tools will include cadence, gait velocity/walking speed, stride length, step length, step width, stride length symmetry ratio and step length symmetry ratio. Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.

Conditions

Hemiplegia

Keywords

auditory, visual, sensorimotor, hemiplegia, gait

Outcome Measures

Primary Outcomes (9)

• Fugl-Meyer Assessment FMA (LE)

  FMA is used to assess sensorimotor function which consists of maximum 28 points for lower extremity and 6 points for speed and coordination. The total summed score of 34 points indicates normal function. Higher the score more is the independence.

  Changes from baseline Fugl-Meyer Assessment FMA (LE) at 3rd week and after 6 weeks

• Dynamic Gait Index (DGI)

  DGI is composed of a total of 8 items. Total score is 24. In total, a score of less than 19/24 is predictive of falls in the elderly. A score of \>22 signifies a safe ambulator.

  Changes from baseline Dynamic Gait Index (DGI) at 3rd week and after 6 weeks

• Cadence

  Number of steps taken per unit time

  Changes from baseline Cadence at 3rd week and after 6 weeks

• Gait velocity/Walking speed

  10 min walk test

  Changes from baseline Gait velocity/Walking speed at 3rd week and after 6 weeks

• Stride length

  Distance between successive ground contacts of the same foot by using measuring tape.

  Changes from baseline Stride length at 3rd week and after 6 weeks

• Step length

  Distance between successive ground contact of the opposite foot by using measuring tape.

  Changes from baseline Step length at 3rd week and after 6 weeks

• Step width

  Transverse linear distance between two successive feet from the centers of heels by using measuring tape.

  Changes from baseline Step width at 3rd week and after 6 weeks

• Step length symmetry ratio

  It will be calculated by dividing step length of paretic limb to non-paretic limb.

  Changes from baseline Step length symmetry ratio at 3rd week and after 6 weeks

• Stride length symmetry ratio

  It will be calculated by dividing the stride length of paretic limb to non-paretic limb.

  Changes from baseline Stride length symmetry ratio at 3rd week and after 6 weeks

Study Arms (2)

Rhtyhmical auditory stimulation and Visual cues (Experimental group)

EXPERIMENTAL

For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. For visual stimulation, white chalk will use to draw visual signals on the ground. For gait recovery, a 10-meter walkway will draw on the floor with parallel lines 2.5cm broad and 90cm long. Interline distance will maintain at 110% of the length of the initial step. Routine rehablitation treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Experimental group will be treated for 45 minutes per session, 3 days per week for 6 weeks.

Other: Rhtyhmical auditory stimulation and Visual cues (Experimental group)

Rhtyhmical auditory stimulation (control group)

OTHER

For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. Routine rehablitation treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Control group will be treated for 45 minutes per session, 3 days per week for 6 weeks.

Other: Rhtyhmical auditory stimulation (Control group)

Interventions

Rhtyhmical auditory stimulation and Visual cues (Experimental group) OTHER

For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. For visual stimulation, white chalk will use to draw visual signals on the ground. For gait recovery, a 10-meter walkway will draw on the floor with parallel lines 2.5cm broad and 90cm long. Interline distance will maintain at 110% of the length of the initial step. Routine recovery treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Experimental group will be treated for 45 minutes per session, 3 days per week for 6 weeks.

Rhtyhmical auditory stimulation and Visual cues (Experimental group)

Rhtyhmical auditory stimulation (Control group) OTHER

For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. Routine recovery treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Control group will be treated for 45 minutes per session, 3 days per week for 6 weeks.

Rhtyhmical auditory stimulation (control group)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range between 45-65 years
• Both male and female genders
• Clinically diagnosed of stroke referred by Neuro physician
• Patients in the chronic stage after 6 months of stroke can walk 10 meters independently.
• Patients with anterior cerebral artery (ACA) and middle cerebral artery (MCA) involvement with the affected side being the dominant side
• Those with Brunnstrom's recovery stages 3 and 4 will take part
• Patients with Mini-Mental State Examination (MMS) score greater than 16.
• According to Modified Ashworth Scale, patients of grades 1 and 1+ will be included. Muscles that go into the spasticity include hip adductors, knee flexors and ankle plantar flexors

You may not qualify if:

• Patients with dementia, depression or productive psychosis will not include.
• Patients having any visual or auditory impairment will be excluded.
• Patients with foot drop
• Recurrent transient ischemic attack (TIA)
• Patients with recurrent stroke

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Tehreem Mukhtar

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sehrish Naureen, MSPT-NM

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tehreem Mukhtar, PhD*

CONTACT

+923134715275; tehreem.mukhtar@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 15, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)