Clinical trial NCT05449301: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Balance
Gait
Mobility
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3D clinical gait assessment (Motion Metrix)
timeFrame: 12 weeks
measure: Wisconsin gait
timeFrame: 12 weeks
measure: Figure of eight walk test
timeFrame: 12 weeks
measure: Biodex balance system
timeFrame: 12 weeks
measure: Timed Up and Go Test
timeFrame: 12 weeks
measure: Berg Balance Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 12 weeks
measure: Stroke specific quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Institute of Rehabilitation Sciences
Study officials:
affiliation: Riphah International University
name: Arshad N Malik, PhD
role: PRINCIPAL_INVESTIGATOR
References: