Comparison of Frequency & Duration of Task Practice During Constraint Induced Movement Therapy

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Standard physiotherapy neuro-rehabilitation; Other: Hour-CIMT; Other: Repetition-CIMT

• Registration Number: NCT04757467
• Lead Sponsor: Riphah International University

Brief Summary

Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area.This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or interference with the normal function of the body controlled by that specific region of the brain. Stroke is usually of two types i.e. Ischemic and hemorrhagic. Ischemic stroke results in reduced or complete obstruction in blood flow in the vessels resulting in ischemia, while a hemorrhagic stroke occurs due to rupture of blood carrying vessels and results in clotting. CIMT has proven effective in rehabilitation of motor functions of lower limbs in many pieces of evidence but still, the evidence is less as compared to the upper extremity. Evidence about improvement in balance and gait using CIMT is very little. In some studies, hours of daily practice for the task has used as a total therapeutic dose measurement. While, in other studies, repetitions of the task have used to calculate the total amount of therapeutic intervention. This study will evaluate the effects of frequency and duration of the task in CIMT on motor functions, gait \& balance of lower limb stroke patients by intervention using these two protocols of CIMT.

Detailed Description

Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area. This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or interference with the normal function of the body controlled by that specific region of the brain. Stroke is usually of two types i.e. Ischemic and hemorrhagic. Ischemic stroke results in reduced or complete obstruction in blood flow in the vessels resulting in ischemia, while a hemorrhagic stroke occurs due to rupture of blood carrying vessels and results in clotting. Both types reduce the supply of oxygen to the parts of the brain and result in cognitive and physical disabilities. Most common physical disabilities e.g. moving certain parts, swallowing, speaking, bowel bladder, coordination \& balance. Other commonly occurring underlying disabilities range from cognitive, emotional to behavioural issues. Constrained Induced Moment Therapy (CIMT) is a therapeutic intervention involving the family of techniques, used most commonly to treat physical disabilities in patients of stroke. These techniques involve restraint of the intact or normal limb over an extended period, in combination with several movement repetitions of task-specific training by the affected limb and lead to improved functional status. Frequency and duration of tasks performed by affected limbs can affect outcomes effectively. Physiologically brain has characteristics of plasticity, which is the basis for CIMT as a treatment. The neurophysiological mechanism that is believed to be underline treatment benefits of CIMT includes overcoming learned outcomes and plastic reorganization of the brain. The brain changes itself when effected extremity is used intensively and repetitively. The physiological effects of CIMT are explained as cortical reorganization, dendritic branching, redundancy learned and synaptic strength Evidence on CIMT interventions for lower limb was quite rare. But many pieces of research supported that CIMT can be used as an equally effective intervention for a lower limb as it is being used for the upper limb. Constraining the lower extremity was difficult and complex as compared to the upper extremity. Improved functional status of the lower limb by treating with CIMT was accompanied by less balance, coordination and short stepped gate. Some researchers focused on repetitions while others focused on forced movements. All the evidence showed improved functional level in the post-stroke lower limb.

Stroke can be managed by a variety of different techniques, one of which is constraint-induced movement therapy (CIMT). This form of rehabilitation focuses on the intensive use of the affected limb while restricting the use of the unaffected limb. The types of restraints used include a splint, a sling, a glove, a mitt and a combination of a sling and a resting hand splint. CIMT has been more commonly practised in the upper limb but after positive results were obtained from the upper extremity protocol, a protocol was developed for the lower extremity as well. A vast number of studies have shown the success of CIMT in treating the reduction of upper limb use in the practical world after traumatic brain injury, cerebral palsy, multiple sclerosis and stroke. A specially adapted form of CIMT for the lower limb has also been successful in treating deficits in the lower limb after spinal cord injury and stroke

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Primary Completion: 2021-02-20
• Study Completion: 2021-02-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Stroke population (ACA)
• Lower limb impairment
• Ability to follow verbal and visual instructions
• No significant cognitive impairment (MMSE score ≥ 24)
• Moderate risk of fall (Tinetti gait and balance score 19-23).
• FMA-LE score of 21 or below out of 34

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Exclusion Criteria

• Other neurological conditions
• Lower limb impairment due to any other reason (fracture, diabetic neuropathy etc.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard physiotherapy neuro-rehabilitation	Standard physiotherapy neuro-rehabilitation	Control Group: Patients included in the control group will receive standard physiotherapy neurorehabilitation protocols.
Hour-CIMT	Hour-CIMT	The task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours.
Repetition-CIMT	Repetition-CIMT	In this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr

Primary Outcome Measures

Name	Time	Method
Tinetti gait and balance test	week 4	Tinetti Balance and Gate Test is a reliable and valid tool to measure gait ability in stroke patients. The Tinetti-gait and balance scale is a reliable and valid tool to measure gait ability in patients with chronic stroke. The inter-rater reliability of the Tinetti-gait scale is high.; Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2.; A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score
Fugl-Meyer assessment scale- lower extremity (FMA-LE)	week 4	Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke. FMA scale has shown high validity and moderate to high reliability. Researches have shown stable responsiveness for this scale, lower extremity (maximum score of 34 points) are recommended as core measures to be used in every stroke recovery and rehabilitation trial.

Trial Locations

Locations (1)

Riphah international university; 🇵🇰 Rawalpindi, Pakistan