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Effects of Unilateral Step Training on Gait and Balance in Stroke Patients

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Rhythmic Auditory Stimulation
Treadmill Training
Unilateral Step Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Balance, Gait, Mobility

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Both Genders.
  2. Age: 40-60 years
  3. Ischemic stroke
  4. Patients having stroke involving Middle Cerebral Artery
  5. Patients in sub-acute (3 months) and chronic phase (6 months) of stroke
  6. Mini-Mental State Exam score > 24
  7. Functional Ambulatory Capacity: 3-5

Exclusion Criteria:

  1. Patients with unstable medical conditions (e.g., DVT, uncontrolled hypertension, uncontrolled diabetes and musculoskeletal injuries)
  2. History of other diseases known to interfere with participation in the study (e.g., heart failure, epilepsy)
  3. Participants with cognitive impairment.
  4. Score of muscle tone on Modified Ashworth Scale: 3-4

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Rhythmic Auditory Stimulation Training Group

Unilateral Step Training Group

Arm Description

The control group will receive Conventional Treadmill training for Gait & balance impairment.

Participants will be trained conventionally (bipedal) on regular treadmill along with Rhythmic Auditory Stimulation.

The participants will be trained with regular treadmill for unilateral step for both paretic and non-paretic lower extremity

Outcomes

Primary Outcome Measures

3D clinical gait assessment (Motion Metrix)
MotionMetrix's 3D Clinical Gait system provides a standard set of gait parameters in which most pathological conditions are reflected. Clinicians can therefore use it to efficiently screen for a variety of conditions and to follow up on corrective measures.
Wisconsin gait
Wisconsin Gait Scale (WGS) is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four subscales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.
Figure of eight walk test
The Figure of 8 Walk Test (F8WT) measures the everyday walking ability with mobility disability. The F8WT tests a participant's gait in both straight and curved paths (r=0.81). The F8WT uses a path where the participant is asked to walk a figure of eight shape around two cones. Scores are recorded in three areas: 1) speed (time for completion), 2) amplitude (number of steps taken), and 3) accuracy or "smoothness".
Biodex balance system
it is used to assess objectively balance and also improving balance, increasing agility, developing muscle tone, treating a wide variety of pathologies. it is easy-to-follow "touchscreen" operation, the Balance System is simple to operate, leading the user step-by-step in testing protocols and training modes in both static and dynamic formats
Timed Up and Go Test
The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down
Berg Balance Scale
The Berg Balance Scale assesses the balance of patients with different neurological disorders. Performance is assessed on different tasks and each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.

Secondary Outcome Measures

Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.
Stroke specific quality of life
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with Stroke. Patients must respond to each question of the SS-QOL regarding the past week. It is a self-report scale containing 49 items in 12 domains: Mobility (6 items), Energy (3 items), Upper extremity function (5 items), Work/productivity (3 items), Mood (5 items), Self-care (5 items), Social roles (5 items), Family roles (3 items), Vision (3 items), Language (5 items), Thinking (3 items) and Personality (3 items).

Full Information

First Posted
July 4, 2022
Last Updated
December 14, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05449301
Brief Title
Effects of Unilateral Step Training on Gait and Balance in Stroke Patients
Official Title
Effects of Unilateral Step Training on Gait and Balance in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
According to the definition proposed by the World Health Organization, "stroke is rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, or leading to death, with no apparent cause other than of vascular origin". Difficulty in walking is present in approximately 80% of stroke survivors. 25% of stroke survivors even after getting rehabilitation have residual gait impairments requiring full assistance after hospital discharge resulting in difficulties in performing basic activities of daily life. Approaches to gait rehabilitation are different based on different models of motor physiology and disease recovery, but most of the approaches are targeting motor impairments during straight walking only as opposed to adaptive walking ability . In order to decrease health care burden effective rehabilitation and prevention is necessary. Multidisciplinary care dedicated for stroke leads to higher independence rates. Conventional gait training regimes including linear parallel bar based gait training and treadmill based gait training protocols do not usually target the angular or rotational component of locomotion. Current study will focus on Unilateral Step Training using a traditional treadmill. This would provide a targeted gait training tool to reduce the risk of fall, improve gait and turning ability and functional activity eventually resulting in greater community participation and involvement in occupational activities. Such an approach could be effective in providing an early targeted and intense training environment similar to task-specific training in contrast to conventional method.
Detailed Description
Gait requires complex integration of motor recruitment of muscles of lower extremity and trunk in addition to constant involvement of neurological and cardiorespiratory system. Impairment in any one of these can result in fall. Turning is a difficult maneuver in gait activity. It requires reciprocating motor recruitment of lower extremity and trunk musculature along with reduced base of support due to single limb stance and with super imposition of pivoting torsional forces. Hence Majority of the falls in post stroke hemi paretic patients occur during turning. In addition to this challenge is further increased due to unequal weight distribution on lower limbs due to lack of motor control. This usually results in asymmetric stepping and increasing gait variability. Conventional and prominent approaches for treatment of post hemiplegia gait abnormalities are mainly centered on the concept of managing spasticity, strength improvement, coordination training and over ground stepping and gait training . Yet there is lack of compelling evidence that any such approaches demonstrate greater efficacy in improving gait and balance related motor function resulting in community integration. One factor is that such interventions lack targeting the angular and asymmetrical component of gait. Conventional gait training regimes including linear parallel bar based gait training and treadmill based gait training protocols do not usually target the asymmetry in gait. Considering this it had been recommended to provide an open environment targeted gait training resulting in utilization of split belt gait training systems in past. Despite promising treatment outcomes of split belt treadmill , there is very little evidence on their usefulness as balance and gait training tools. Though UST training had been found to be effective in improving step length asymmetry but Similar to Rotational treadmill training and split belt treadmill training no published data is available objectively evaluating spatio-temporal gait parameters (including speed, step width, stride asymmetry and cadence), balance, turning and quality of life. Additionally results from previous studies showing UST as effective approach in improving step asymmetry in stroke patients lack generalizability considering the fact that they comprised of a single session only. Current study will focus on Unilateral Step Training using a traditional treadmill. This would provide a targeted gait training tool to reduce the risk of fall, improve gait and turning ability and functional activity eventually resulting in greater community participation and involvement in occupational activities. Such an approach could be effective in providing an early targeted and intense training environment similar to task-specific training in contrast to conventional method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Balance, Gait, Mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive Conventional Treadmill training for Gait & balance impairment.
Arm Title
Rhythmic Auditory Stimulation Training Group
Arm Type
Experimental
Arm Description
Participants will be trained conventionally (bipedal) on regular treadmill along with Rhythmic Auditory Stimulation.
Arm Title
Unilateral Step Training Group
Arm Type
Experimental
Arm Description
The participants will be trained with regular treadmill for unilateral step for both paretic and non-paretic lower extremity
Intervention Type
Other
Intervention Name(s)
Rhythmic Auditory Stimulation
Intervention Description
The participants will receive RAS on regular treadmill for balance and gait improvement. one session per day, 3 session per week for consecutively 12 weeks.
Intervention Type
Other
Intervention Name(s)
Treadmill Training
Intervention Description
participants will be trained conventionally (bipedal) on regular treadmill. one session per day, 3 session per week for consecutively 12 weeks.
Intervention Type
Other
Intervention Name(s)
Unilateral Step Training
Intervention Description
Patients will be trained on regular treadmill for both paretic and non paretic lower extremity. Single session per day, 3 session per week for consecutively 12 weeks.
Primary Outcome Measure Information:
Title
3D clinical gait assessment (Motion Metrix)
Description
MotionMetrix's 3D Clinical Gait system provides a standard set of gait parameters in which most pathological conditions are reflected. Clinicians can therefore use it to efficiently screen for a variety of conditions and to follow up on corrective measures.
Time Frame
12 weeks
Title
Wisconsin gait
Description
Wisconsin Gait Scale (WGS) is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four subscales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.
Time Frame
12 weeks
Title
Figure of eight walk test
Description
The Figure of 8 Walk Test (F8WT) measures the everyday walking ability with mobility disability. The F8WT tests a participant's gait in both straight and curved paths (r=0.81). The F8WT uses a path where the participant is asked to walk a figure of eight shape around two cones. Scores are recorded in three areas: 1) speed (time for completion), 2) amplitude (number of steps taken), and 3) accuracy or "smoothness".
Time Frame
12 weeks
Title
Biodex balance system
Description
it is used to assess objectively balance and also improving balance, increasing agility, developing muscle tone, treating a wide variety of pathologies. it is easy-to-follow "touchscreen" operation, the Balance System is simple to operate, leading the user step-by-step in testing protocols and training modes in both static and dynamic formats
Time Frame
12 weeks
Title
Timed Up and Go Test
Description
The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down
Time Frame
12 weeks
Title
Berg Balance Scale
Description
The Berg Balance Scale assesses the balance of patients with different neurological disorders. Performance is assessed on different tasks and each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.
Time Frame
12 weeks
Title
Stroke specific quality of life
Description
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with Stroke. Patients must respond to each question of the SS-QOL regarding the past week. It is a self-report scale containing 49 items in 12 domains: Mobility (6 items), Energy (3 items), Upper extremity function (5 items), Work/productivity (3 items), Mood (5 items), Self-care (5 items), Social roles (5 items), Family roles (3 items), Vision (3 items), Language (5 items), Thinking (3 items) and Personality (3 items).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both Genders. Age: 40-60 years Ischemic stroke Patients having stroke involving Middle Cerebral Artery Patients in sub-acute (3 months) and chronic phase (6 months) of stroke Mini-Mental State Exam score > 24 Functional Ambulatory Capacity: 3-5 Exclusion Criteria: Patients with unstable medical conditions (e.g., DVT, uncontrolled hypertension, uncontrolled diabetes and musculoskeletal injuries) History of other diseases known to interfere with participation in the study (e.g., heart failure, epilepsy) Participants with cognitive impairment. Score of muscle tone on Modified Ashworth Scale: 3-4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arshad N Malik, PhD
Phone
03334503754
Email
arshad.nawaz@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Khalid, MsNMPT
Phone
03444218174
Email
sana.khalid@fui.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshad N Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furqan A Siddiqi, PhD
Phone
0092515788151
Ext
602
Email
furqan@fui.edu.pk
First Name & Middle Initial & Last Name & Degree
Sana Khalid, PhD*

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Unilateral Step Training on Gait and Balance in Stroke Patients

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