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

NCT ID: NCT05449301

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-01

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.

Conditions

Stroke

Keywords

Balance; Gait; Mobility

Study Design

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

Study Groups

Control Group

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

Group Type: ACTIVE_COMPARATOR

Treadmill Training

Intervention Type: OTHER

participants will be trained conventionally (bipedal) on regular treadmill. one session per day, 3 session per week for consecutively 12 weeks.

Rhythmic Auditory Stimulation Training Group

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

Group Type: EXPERIMENTAL

Rhythmic Auditory Stimulation

Intervention Type: OTHER

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.

Treadmill Training

Intervention Type: OTHER

participants will be trained conventionally (bipedal) on regular treadmill. one session per day, 3 session per week for consecutively 12 weeks.

Unilateral Step Training Group

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

Group Type: EXPERIMENTAL

Unilateral Step Training

Intervention Type: OTHER

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.

Interventions

Rhythmic Auditory Stimulation

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

Treadmill Training

participants will be trained conventionally (bipedal) on regular treadmill. one session per day, 3 session per week for consecutively 12 weeks.

Intervention Type: OTHER

Unilateral Step Training

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arshad N Malik, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Foundation University Institute of Rehabilitation Sciences

Islamabad, , Pakistan

Countries

Pakistan

Central Contacts

Arshad N Malik, PhD

Role: CONTACT

Phone: 03334503754

Email: arshad.nawaz@riphah.edu.pk

Sana Khalid, MsNMPT

Role: CONTACT

Phone: 03444218174

Email: sana.khalid@fui.edu.pk

Facility Contacts

Furqan A Siddiqi, PhD

Role: primary

Other Identifiers

REC/01203 Sana Khalid

Identifier Type: -

Identifier Source: org_study_id