Effectiveness of Paretic Lower Limb Loading During Over-ground Training Among Stroke Survivors
Condition: Stroke; Hemiparesis;Poststroke/CVA
MeSH terms: Stroke; Paresis
Study type: Interventional

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).
    

Intervention name(s): Warm-up (5 minutes); Conventional physiotherapy exercise (15 minutes); Over-ground training with lower limb loading (15-25 minutes)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will benefit from passive stretches of hamstrings, calf muscles including a range of motion (ROM) exercise to the lower limbs as mat exercises.; The conventional treatments will be active-assisted and free active exercises to the lower limbs on the mat for five (5) minutes. This will be followed by strength training such as sit-to-stand exercises for five (5) minutes and squatting exercises for five (5) minutes prior to the over-ground training.; Participants will perform the over-ground training exercise with an external 1.5kg load on the paretic lower limb placed 2cm above the ankle joint. Before commencing the over-ground training, all the participants will observe a pre-exercise rest period of about two (2) minutes during which their heart rate and blood pressure measurements will be recorded.
The over-ground training will involve the patients walking within a demarcated path. Each participant will be instructed to stand and walk 15meters to and fro for five (5) minutes after which they will be asked to stop and rest for two (2) minutes. The over ground training exercise will be repeated 3 times in the first 2 weeks of the training (15 minutes); 4 times in weeks 3-4 of the training (20 minutes); and 5 times in weeks 5-8 of the training (25 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lower limb loading; Over-ground training; Spatiotemporal gait parameters; Gait symmetry parameters; Motor function; Randomized Controlled Trial