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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Standard physiotherapy neuro-rehabilitation
Repetition-CIMT
Hour-CIMT
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, constraint induced movement therapy, rehabilitation

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

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

Sites / Locations

  • Riphah international university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard physiotherapy neuro-rehabilitation

Repetition-CIMT

Hour-CIMT

Arm Description

Control Group: Patients included in the control group will receive standard physiotherapy neurorehabilitation protocols.

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

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer assessment scale- lower extremity (FMA-LE)
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.
Tinetti gait and balance test
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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
June 18, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04757467
Brief Title
Comparison of Frequency & Duration of Task Practice During Constraint Induced Movement Therapy
Official Title
Comparison of Frequency & Duration of Task Practice During Constraint-Induced Movement Therapy on Lower Limb in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, constraint induced movement therapy, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard physiotherapy neuro-rehabilitation
Arm Type
Active Comparator
Arm Description
Control Group: Patients included in the control group will receive standard physiotherapy neurorehabilitation protocols.
Arm Title
Repetition-CIMT
Arm Type
Experimental
Arm Description
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
Arm Title
Hour-CIMT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy neuro-rehabilitation
Intervention Description
Treatment interventions which will be used for this group Passive range of movement exercises. Therapeutic positioning of the lower limb. Strengthening exercise for the lower limb. Over-ground gait training 5 times a week for 4 weeks. First week= 30 min exercise Second week= 1hour exercise Third week= 1hour and 30 min exercise Fourth week= 2 hours exercise All the treatment protocols will be applied to the patient for 5 times a week for consecutive 4 weeks. Interventions will be performed in the clinic and through home-based exercises using patient education
Intervention Type
Other
Intervention Name(s)
Repetition-CIMT
Intervention Description
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. Sit-to-Stand Forward and Backward stepping Stair Climbing and Descending (only the first stair will be used) Side-to-Side stepping with the affected limb Each task will be performed 10 times per session in the first week and 2 sessions a day. In the second week, each task will be performed 20 times per session for 2 sessions a day. In the third week, each task will be performed 30 times per session for 2 sessions a day.In the fourth week, each task will be performed 40 times per session for 2 sessions a day. The session will be held 5 days in a week for the period of consecutive 4 weeks. Total of 1000 repetitions of the above mentions tasks will be performed in 4 weeks' study time by every participant
Intervention Type
Other
Intervention Name(s)
Hour-CIMT
Intervention Description
A 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. (15) Sessions will be held 5 days in the week for a period of consecutive 4 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer assessment scale- lower extremity (FMA-LE)
Description
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.
Time Frame
week 4
Title
Tinetti gait and balance test
Description
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
Time Frame
week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: Other neurological conditions Lower limb impairment due to any other reason (fracture, diabetic neuropathy etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Afridi, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah international university
City
Rawalpindi
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9803954
Citation
Warlow CP. Epidemiology of stroke. Lancet. 1998 Oct;352 Suppl 3:SIII1-4. doi: 10.1016/s0140-6736(98)90086-1. No abstract available.
Results Reference
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PubMed Identifier
23652265
Citation
Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum In: Stroke. 2019 Aug;50(8):e239.
Results Reference
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PubMed Identifier
19228849
Citation
Sridharan SE, Unnikrishnan JP, Sukumaran S, Sylaja PN, Nayak SD, Sarma PS, Radhakrishnan K. Incidence, types, risk factors, and outcome of stroke in a developing country: the Trivandrum Stroke Registry. Stroke. 2009 Apr;40(4):1212-8. doi: 10.1161/STROKEAHA.108.531293. Epub 2009 Feb 19.
Results Reference
background
PubMed Identifier
12554390
Citation
Hartman-Maeir A, Soroker N, Oman SD, Katz N. Awareness of disabilities in stroke rehabilitation--a clinical trial. Disabil Rehabil. 2003 Jan 7;25(1):35-44.
Results Reference
background
PubMed Identifier
22378476
Citation
Fuzaro AC, Guerreiro CT, Galetti FC, Juca RB, Araujo JE. Modified constraint-induced movement therapy and modified forced-use therapy for stroke patients are both effective to promote balance and gait improvements. Rev Bras Fisioter. 2012 Apr;16(2):157-65. doi: 10.1590/s1413-35552012005000010. Epub 2012 Mar 1.
Results Reference
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PubMed Identifier
16321129
Citation
Hakkennes S, Keating JL. Constraint-induced movement therapy following stroke: a systematic review of randomised controlled trials. Aust J Physiother. 2005;51(4):221-31. doi: 10.1016/s0004-9514(05)70003-9.
Results Reference
background
PubMed Identifier
22207472
Citation
Zipp GP, Winning S. Effects of constraint-induced movement therapy on gait, balance, and functional locomotor mobility. Pediatr Phys Ther. 2012 Spring;24(1):64-8. doi: 10.1097/PEP.0b013e31823e0245.
Results Reference
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Comparison of Frequency & Duration of Task Practice During Constraint Induced Movement Therapy

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