- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404971
Effects of Joint Integrity Exercises Verses Mirror Therapy in Hemineglect Stroke Survivors
Effects of Joint Integrity Exercises Verses Mirror Therapy on Proprioception and Functional Rehabilitation of Upper Limb in Hemineglect Stroke Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Lahore General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hemi neglect stroke patients after performing line bisection test
- Patients having Mini mental State Examination score above 24
- Patients having Catherine Bergego scale score above 27
- Patients having minimum MIQ-3 score 6 or above
- Sub-acute phase (2 Months) following stroke
Exclusion Criteria:
- Patients with neurological conditions other than stroke including Parkinson's, Alzheimer and Multiple sclerosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Joint integrity exercises
Tactile stimulation with the various textures will be applied to the patients with three strokes followed by 3 sec rest period. Kinaesthetic stimulations will be given to the patients to increase proprioception proprioception in neglected limb in sitting position, the limb on the affected side of the body is supported and moved by the examiner in various directions but movement is only at one joint at a time. Stereognosis by placing the object in the patient's hand for a maximum 30 seconds with close eyes. Identification is by naming, description or by pair matching with an identical set. |
patients with three strokes followed by 3 sec rest period.
Kinaesthetic stimulations will be given to the patients to increase proprioception proprioception in neglected limb in sitting position, the limb on the affected side of the body is supported and moved by the examiner in various directions but movement is only at one joint at a time.
Stereognosis by placing the object in the patient's hand for a maximum 30 seconds with close eyes.
Identification is by naming, description or by pair matching with an identical set.
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|
Active Comparator: Mirror therapy
A 5 cm × 35 cm mirror will be placed vertically between the upper limbs on the table, with the reflecting surface facing the uninjured limb.
Patients will be asked to observe the motion of the upper limb on the uninjured side and imagine that the limb on the affected side was in motion, imagine the motion of the affected limb the same as that observed on the uninjured side, and complete 6 movements including shoulder joint forward flexion, elbow joint flexion and extension, forearm forward and backward rotation, wrist joint flexion and extension, finger extension and grasping, and thumb abduction.
The participants will be asked to perform each movement for 5 min and try to reach the maximum range of motion of the joints.
Training will be completed for 30 min per day) Session will be 3 days per week.
Per day session will be for 30 minutes.
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A 5 cm × 35 cm mirror will be placed vertically between the upper limbs on the table, with the reflecting surface facing the uninjured limb.
Patients will be asked to observe the motion of the upper limb on the uninjured side and imagine that the limb on the affected side was in motion, imagine the motion of the affected limb the same as that observed on the uninjured side, and complete 6 movements including shoulder joint forward flexion, elbow joint flexion and extension, forearm forward and backward rotation, wrist joint flexion and extension, finger extension and grasping, and thumb abduction.
The participants will be asked to perform each movement for 5 min and try to reach the maximum range of motion of the joints.
Training will be completed for 30 min per day) Session will be 3 days per week.
Per day session will be for 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fugl-Meyer Upper Extremity Assessment
Time Frame: 4 weeks
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The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment.
It is used for assessment of motor function of upper extremity.
The FMUE Scale comprises 33 items, each item scored on 3 point ordinal scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Total score for motor function is 66.
Reading will be at Baseline and after 4 weeks
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4 weeks
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Nottingham sensory assessment
Time Frame: 4 weeks
|
NSA is used in clinical trials in stroke patients to test effectiveness of different interventions. It is used for sensory examination of tactile sensation, kinesthesia and stereognosis. Tactile scoring is 0-2, where 0 = absent, 1 = impaired and 2 = normal. Stereognosis scoring is 0-2, where 0 = absent, 1 = impaired and 2 = normal. Kinesthesia scoring 0-3, where 0 = absent, 1 = appreciation of movement taking place, 2 = direction of movement sense and 3 = joint position sense. Reading will be at Baseline and after 4 weeks |
4 weeks
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Motor assessment scale
Time Frame: 4 weeks
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This scale is designed to assess the return of function following a stroke or other neurological impairment. The test looks at a patient's ability to move with low tone or in a synergistic pattern and finally move actively out of that pattern into normal movement. It consists of 9 sections. The higher the score, the higher functioning the patient has on the affected side. High Score = 54 and Low Score = 0. Reading will be at Baseline and after 4 weeks |
4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.
- Harrison DH, DeVore BB, Campbell RW, Harrison PK. Hallucinations and hemispatial neglect following right middle cerebral artery cerebrovascular accident: Left gaze bias with left sensory hemineglect syndrome. 2017
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/21/0210 Faiza Tabassam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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