Clinical trial NCT05097391: Effectiveness of Paretic Lower Limb Loading During Over-ground Training Among Stroke Survivors
Official title: Effectiveness of Lower-limb Loading During Over-ground Training on Selected Gait Parameters and Motor Function of Stroke Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis;Poststroke/CVA
Keywords: Lower limb loading
Over-ground training
Spatiotemporal gait parameters
Gait symmetry parameters
Motor function
Randomized Controlled Trial
Lead sponsor: Bayero University Kano, Nigeria
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into either group A (experimental: over-ground walking with lower limb loading) or group B (control: over-ground walking without lower limb loading).

Both groups will receive a warm-up consisting of passive stretching to hamstrings and calf muscles, and a range of motion exercise to the lower limbs for 5 min. Participants allocated to group A will receive conventional exercises (15 min) and then rest for 2 min, then proceeded with overground walking training with lower limb loading (15-25 min), and rest for 2 min. Those assigned to group B will receive the same conventional exercises (15 min) and overground walking but without lower limb loading.

Treatment in both groups will be delivered thrice weekly for 8 weeks.
Primary purpose: TREATMENT

Brief summary: Post-stroke gait deviations contribute to significant functional disability, impaired walking ability and poor quality of life. Prior studies suggest that gait training with paretic lower limb loading may improve gait parameters and walking ability in post-stroke. However, most gait training methods used in these studies are not readily available, and studies using cheaper methods are limited.

Detailed description: Stroke is the second leading cause of death and a major public health problem in both developed and developing countries. It is one of the most common causes of long-term disabilities among adults.

Stroke survivors exhibit varying neurological deficits and impairments including sensory, cognitive, perceptual, emotional, speech and motor such as gait impairments. The most important motor deficit after a stroke is the paresis of the affected side, which reduces the capacity of the paretic lower limb to maintain normal functions such as balance, initiation, and control of movements, and this negatively affects their gait.

Gait is altered post-stroke due to basic motor impairments such as altered muscle tone, lack of selective motor control, abnormal reflexes, poor balance, and muscle weakness. Gait impairment is one of the hallmarks of stroke, and many survivors are reported to have slow motor recovery in the affected lower extremity years after the stroke, which impairs their gait quality and contributes to persistent gait asymmetry. Gait asymmetry implies a significant imbalance of functional activities between two sides of the body or lower limb.

Gait symmetry is a valuable feature of gait quality, and its abnormality negatively affects gait parameters. Post-stroke, 44%-62% of the survivors showed asymmetry in the spatial gait parameters, while 48%-82% developed asymmetry in the temporal gait parameters.

After a stroke, the paretic limb exhibits a prolonged period of swing and a reduced period of stance; as a result, decreased swing time and increased stance time are seen in the non-paretic limb. These changes are believed to result from decreased walking speed as well as disturbances in other gait parameters between the paretic and non-paretic limbs, which may limit gains from rehabilitation. Despite rehabilitation efforts, self-loading and self-initiation of gait are typically ineffective in stroke patients. Stroke rehabilitation now focuses on improving load transfer onto the paretic limb to enhance proprioception and gait symmetry by providing an external source of limb loading to augment patient effort. Many survivors usually do not have significant improvement in gait function. This is often due to inefficient weight application (limb loading) on the affected side, causing non-linear limb load transfer.

Though there have been numerous interventions to manage gait in stroke survivors, using weight during over-ground walk training on stroke survivors has not been thoroughly evaluated. However, a cross-sectional study has found that weight application at the knee and ankle were both found to influence the spatiotemporal gait parameters and gait symmetry, with ankle loading having more influence on more parameters. This study is hoped to serve as a follow-up RCT to the cross-sectional study by Bala (2019).

Eligibility criteria: Inclusion Criteria:

1. Unilateral ischemic or hemorrhagic stroke occurring at least 3 months before enrolment
2. Male or female between the age of 20 and 70 years
3. Having a Modified Rankin Scale (MRS) scores of 1, 2, or 3, and also able to walk at least 10 meters independently without an assistive device
4. Ability to follow verbal instructions.

Exclusion Criteria:

1. Cognitive impairments
2. Visual impairments
3. Musculoskeletal disorders that may affect gait such as arthritis
4. Other neurological disorders such as Parkinson's disease, multiple sclerosis
5. Cardio-respiratory conditions that may limit participation such as atelectasis
6. Concurrent participation in other interventional clinical trials.

Primary outcomes:
measure: Spatial gait parameters and symmetry
timeFrame: Change from baseline spatial gait parameters at 4 weeks; Change from baseline spatial gait parameters at 8 weeks
measure: Temporal gait parameters and symmetry
timeFrame: Change from baseline temporal gait parameters at 4 weeks; Change from baseline temporal gait parameters at 8 weeks
measure: The Lower limb motor functions
timeFrame: Change from baseline lower limb motor function at 4 weeks; Change from baseline lower limb motor function at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Muhammadu Abdullahi Wase Teaching Hospital
Study officials:
affiliation: Muhammadu Abdullahi Wase Teaching Hospital, Kano State
name: Abdulhamid U Maje, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: