Introduction
Methods
Aim of the trial
Study description and study design
Design
Sample size
Allocation
Participant timelines
Eligibility criteria
Arms and interventions
Experimental group intervention
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Maximum duration of the protocol will be 120 min with 20–25 min for each sensory modality with maximum of 5 min for each level of intervention and intermittent rest period. In case, there is no impairment of a certain modality, the training time for that modality will be equally distributed to other impaired ones, with a maximum of 40 min for each.
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The order of modality training will be in random order in each session.
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The training will be imparted in order of lower level of therapy to the higher ones.
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Sharp sensory stimulus will be in safer limits.
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Mirror therapy (MT) activities will be graded from unilateral (non-paretic limb performance) to bimanual (simultaneously moving on both sides).
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MT protocol will be provided as per the published study (Arya et al. 2018) [15]
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Sensory imagination (2 min) for each stimulus will be provided to prior to every sub-session of training.
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Other activities will be graded from bilateral to unilateral (constraining the non-paretic limb).
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Gradation of activities will also be done from visual feedback to vision occluded.
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Variety of sensori-motor objects / activities should be utilized for imparting the intervention.
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Auditory cues, guidance, motivation will be provided by the therapist as per the requirement.
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The constraint will be provided using a sling for sensory-functional training for higher stage patients.
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Therapy for different type of sensory deficits will be provided separately.
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Therapy for sensory deficit will be provided as per the motor recovery stage of the hand.
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Levels of intervention will range from neural activation using mirror therapy and sensory imagination to active perception of stimuli and sensory motor usage in non-functional to meaningful functional items.
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Therapy will be provided in distraction free and calm environment.
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Blindfolding the subject during the therapy session will be performed as per the need.
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The therapy may be modulated as per the extent of sensory deficit of specific type.
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Two minutes rest break after training of each modality will be provided
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Variety of items with similar texture / therapeutic value will be used.
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Home program comprising of functional touch of variety of meaningful objects/ sensation will be provided throughout the day for 2–3 h during the entire 8-week.
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The home program will be supervised through a log book maintained by patient/care taker regarding the sensory-functional usage.
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Level I: Neural Activation
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Mirror therapy (illusion of the normal sensory perception using mirror-box therapy);
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Sensory imagery (imagery of the normal sensory perception)
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These techniques may enhance the neural activation of the sensory cortex. The activation will provide a reasonable base for active sensory training. The perception such as various texture, size, shape, and objects will be used.
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Level II: Active Sensory-Training
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The active sensory training for modalities such as tactile awareness and localization, texture recognition, and stereognosis will be provided by prolong-duration, meaningful and bimanual sensory perception.
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Level III: Sensori-Motor therapy
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Motor therapy will be provided using specific stimuli (textured, shape) during activities.
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Level IV: Sensory-Functional therapy
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Prolong-duration functional therapy using various meaningful shapes, sizes and textured objects of daily use will be provided.
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Sensory Impairment | Level of therapy | Motor Recovery Stage | |||
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BRS-H 1 & 2 | BRS-H 3 | BRS-H 4 | BRS-H 5 & 6 | ||
Light touch | Level-I | MT (unilateral) – cotton / wool /soft toy | MT (bimanual) – cotton / wool /soft toy | MT (bimanual) – grasp-release, lateral prehension-release using cotton / wool /soft toy | MT (bimanual) – grasp and release, prehensile activity using cotton / wool /soft toy |
Level-II | Bilateral and unilateral perception of cotton / wool / soft toy (therapist applied) | Bilateral and unilateral perception of cotton / wool / soft toy | Bilateral and unilateral perception of cotton / wool / soft toy by grasp-release, lateral prehension and release | Bilateral and unilateral perception of cotton / wool / soft toy by prehensile activity | |
Level-III | Bilateral movements of upper limb joints holding cotton /wool /soft toy | Unilateral movements of upper limb joints holding cotton /wool /soft toy | Unilateral perception of cotton / wool / soft toy by grasp-release, lateral prehension and release | Unilateral movement (constraining the non-paretic limb) for prehensile activity using cotton / wool /soft toy | |
Level-IV | Bilateral functional tasks – lifting cloth / pillow | Unilateral functional tasks – lifting cloth / pillow | Unilateral functional tasks – grasp-release, lateral prehension and release of cloth / pillow | Unilateral functional tasks (constraining the non-paretic limb) – grasp-release, lateral prehension and release of cloth / pillow | |
Pressure | Level-I | MT (unilateral) - clay (graded resistance) activity, ball squeezing | MT (bimanual) - clay (graded resistance) activity, ball squeezing | MT (bimanual) – grasp-release, lateral prehension and release of - clay (graded resistance) activity, ball | MT (bimanual) – pinching clay (graded resistance) activity |
Level-II | Bilateral and unilateral perception of clay (graded resistance) activity, ball squeezing (therapist applied) | Bilateral and unilateral perception of clay (graded resistance) activity, ball squeezing | Bilateral and unilateral perception of– grasp-release, lateral prehension and release - clay (graded resistance) activity, ball | Bilateral and unilateral perception of pinching clay (graded resistance) activity | |
Level-III | Bilateral movements of upper limb joints holding high- density foam cylindrical blocks | Unilateral movements of upper limb joints holding high- density foam cylindrical blocks | Unilateral movements of grasp-release, lateral prehension and release - high- density foam blocks | Unilateral movement (constraining the non-paretic limb) for pinching clay (graded resistance) activity | |
Level-IV | Bilateral movements of upper limb joints holding textured water glass/bottle | Uilateral movements of upper limb joints holding textured water glass/bottle | Unilateral movements of grasp-release, lateral prehension and release - textured water glass/bottle, key, cardboard | Unilateral functional tasks (constraining the non-paretic limb) – pinching and picking grains/coins | |
Pin prick | Level-I | MT (unilateral)– Scrubber / Steel wool/Velcro (rough) | MT (bimanual) – Scrubber / Steel wool/Velcro (rough) | MT (bimanual)– grasp-release, lateral prehension and release of Scrubber / Steel wool/Velcro (rough) | MT (bimanual)– prehensile activity using Scrubber / Steel wool/Velcro (rough |
Level-II | Bilateral and unilateral perception of Scrubber / Steel wool/Velcro (therapist applied) | Bilateral and unilateral perception of Scrubber / Steel wool/Velcro | Unilateral perception of grasp-release, lateral prehension and release of Scrubber / Steel wool/Velcro | Unilateral perception of prehensile activity of items textured with Scrubber / Steel wool/Velcro | |
Level-III | Bilateral movements of upper limb joints holding textured (Scrubber / Steel wool/Velcro) cylindrical blocks | Unilateral movements of upper limb joints holding textured (Scrubber / Steel wool/Velcro) cylindrical blocks | Unilateral movements of upper limb joints comprises grasp-release, lateral prehension and release of textured (Scrubber / Steel wool/Velcro) blocks | Unilateral movements (constraining the non-paretic limb) of upper limb joints comprises prehensile activity of items textured with Scrubber / Steel wool/Velcro | |
Level-IV | Bilateral movements of upper limb joints holding textured (Scrubber / Steel wool/Velcro) water glass/bottle | Unilateral movements of upper limb joints holding textured (Scrubber / Steel wool/Velcro) water glass/bottle | Unilateral movements of grasp-release, lateral prehension and release of textured (Scrubber / Steel wool/Velcro) daily use items | Unilateral movement (constraining the non-paretic limb) of prehensile activity of daily use items textured with Scrubber / Steel wool/Velcro | |
Sharp-blunt discrimination | Level-I | MT (unilateral)- Dellon’s Discriminator disc (therapist applied) | MT (bimanual) - Dellon’s Discriminator disc (therapist applied) | MT (bimanual) – sharp and blunt textured items alternatively | MT (bimanual) – prehensile activity of sharp and blunt textured items |
Level-II | Bilateral and unilateral sharp and blunt discrimination (therapist applied) | Bilateral and unilateral sharp and blunt discrimination | Unilateral sharp and blunt discrimination | Unilateral prehensile activity of sharp and blunt textured items | |
Level-III | Bilateral movements of upper limb joints holding dual spikes/textured (blunt and sharp) cylindrical blocks | Unilateral movements of upper limb joints holding dual spikes/textured (blunt and sharp) cylindrical blocks | Unilateral movements of upper limb joints comprises sharp and blunt textured items along with manipulation; grasp-release, lateral prehension and release | Unilateral movements (constraining the non-paretic limb) of upper limb joints comprises prehensile activity of sharp and blunt textured items | |
Level-IV | Bilateral movements of upper limb joints holding dual spikes/textured (blunt and sharp) water glass/bottle | Unilateral movements of upper limb joints holding dual spikes/textured (blunt and sharp) water glass/bottle | Unilateral sharp and blunt textured daily use items manipulation; grasp-release, lateral prehension and release | Unilateral movements (constraining the non-paretic limb) of upper limb joints comprises prehensile activity of sharp and blunt textured daily use items | |
Proprioception | Level-I | MT (unilateral)- task-based movements of shoulder, elbow, wrist; Movement of non-paretic upper limb and perceiving the limb position and movement with vision occluded. | MT (bimanual) - task-based movements of shoulder, elbow, wrist; Movement of the upper limbs and perceiving the limb position and movement with vision occluded. | MT (bimanual) - task-based movements of shoulder, elbow, wrist, hand, thumb and fingers; Movement of the joints and perceiving the limb position and movement with vision occluded. | MT (bimanual) - task-based movements of all upper limb especially fingers; Movement of the joints and perceiving the finger position and movement with vision occluded. |
Level-II | Bilateral movements of shoulder, elbow, wrist with visual feedback followed by vision occluded | Unilateral movements of shoulder, elbow, wrist with visual feedback followed by vision occluded | Unilateral movements of shoulder, elbow, wrist hand, thumb and fingers; with visual feedback followed by vision occluded | Unilateral movements (constraining the non-paretic limb) of all upper limb especially fingers; with visual feedback followed by vision occluded | |
Level-III | Bilateral activity-based movements of shoulder, elbow, wrist with visual feedback followed by vision occluded | Unilateral activity-based movements of shoulder, elbow, wrist with visual feedback followed by vision occluded | Unilateral activity-based movements of shoulder, elbow, wrist hand, thumb and fingers; with visual feedback followed by vision occluded | Unilateral activity based movements (constraining the non-paretic limb) of all upper limb especially fingers; with visual feedback followed by vision occluded | |
Level-IV | Bilateral functional task-based movements of shoulder, elbow, wrist with visual feedback followed by vision occluded | Unilateral functional task-based movements of shoulder, elbow, wrist with visual feedback followed by vision occluded | Unilateral functional task-based movements of shoulder, elbow, wrist, hand, thumb and fingers; with visual feedback followed by vision occluded | Unilateral functional task-based movements (constraining the non-paretic limb) of all upper limb especially fingers; with visual feedback followed by vision occluded | |
Stereognosis | Level-I | MT (unilateral) – 10 objects | MT (bimanual) – 10 objects; similar objects on both the sides. | MT (bimanual) – 10 objects; similar objects on both the sides; manipulation of objects by grasp-release, lateral prehension and release | MT (bimanual) – 10 small objects such as beads; similar objects on both the sides along with the manipulation of objects |
Level-II | Perceiving the 10 objects bilaterally with visual feedback followed by vision occluded | Perceiving the 10 objects unilaterally with visual feedback followed by vision occluded | Perceiving the 10 objects unilaterally with visual feedback followed by vision occluded; manipulation of objects by grasp-release, lateral prehension and release | Perceiving the 10 small objects unilaterally with visual feedback followed by vision occluded | |
Level-III | Bilateral manipulation (reaching, lifting, placing) of 10 objects with visual feedback followed by vision occluded | Unilateral manipulation (reaching, lifting, placing) of 10 objects with visual feedback followed by vision occluded | Unilateral manipulation (reaching, lifting, placing, grasp-release, lateral prehension and release) of 10 objects (mixed together) with visual feedback followed by vision occluded | Unilateral manipulation (reaching, lifting, placing, in-hand manipulation) of 10 small objects (mixed together) with visual feedback followed by vision occluded | |
Level-IV | Bilateral manipulation (reaching, lifting, placing) of variety of daily use items with visual feedback followed by vision occluded | Unilateral manipulation (reaching, lifting, placing) of variety of daily use items with visual feedback followed by vision occluded | Unilateral manipulation (reaching, lifting, placing, grasp-release, lateral prehension and release) of 10 daily use items (mixed together) with visual feedback followed by vision occluded | Unilateral manipulation (reaching, lifting, placing, in-hand manipulation) of 10 small daily use objects (mixed together) with visual feedback followed by vision occluded |