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IRCT20210615051585N5 IRCT 2022-05-07 Shifa Tameer e Millat University Effect of Mirror therapy and home dexterity program in improving hand function of Parkinson's patients Effectiveness of mirror visual feedback therapy combined with home dexterity program as compared to home dexterity program in improving hand function of patients with Parkinson's disease 2022-03-21 anticipated 30 Complete https://irct.ir/trial/62615 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment was used for treatment using a sealed envelope. For that, 30 sheets of aluminum paper are properly cut. This paper should be double the size of the paper. 15 Sheets of Carbon paper cut into appropriate size according to the paper used. A standard-sized square paper was taken in which group "(Mirror visual feedback therapy combined with home dexterity program)" was marked. In this way, 15 papers were prepared marked with "(Mirror visual feedback therapy combined with home dexterity program)" and 15 square-shaped papers marked with "(Home dexterity program)". The sheet of paper on which either (Mirror visual feedback therapy combined with home dexterity program) or (Home dexterity program) was marked was folded to fit the envelope. A sheet of Carbon paper was placed on the top of the folded paper (marked either (Mirror visual feedback therapy combined with home dexterity program) or (Home Dexterity Program) facing the envelope. Then the sheet of Aluminum foil was wrapped on the carbon paper (with folded paper inside). All the above prepared were placed in the envelope (which was completely opaque), the envelope was then sealed. In this way 15 envelops of "(Mirror visual feedback therapy combined with home dexterity program)" and 15 envelops of "(Home Dexterity Program)" were prepared with a total number of 30 envelopes. These 30 envelopes were then thoroughly shuffled like a deck of cards. The envelopes were then marked with numbers 1-30. Each participant picked the envelope in order from 1-30 and was given an intervention (Mirror visual feedback therapy combined with home dexterity program or Home Dexterity program) accordingly, Blinding description: Only the researcher doing the study knows which treatment or intervention the participant is receiving. It makes results less likely to be biased. For that, they received an additional device that is not connected and they feel they are receiving treatment apart from their actual treatment. N/A Parkinson's patients with impaired hand dexterity. Intervention 1: Mirror visual feedback therapy combined with home dexterity program group: This group will receive Mirror visual feedback therapy combined with a home-based dexterity Program for 1 hour 3 times a week for 6 weeks. A patient will have to perform six various types of exercises, either bi-manually or unimanual. Both hands will have to be trained equally. A mirror box will be used for the performance of Manual dexterity. A plastic foldable triangular box with an attached mirror on a side will be kept on a table so one of the hands of the subject will be reflected by the mirror and another hand will be hidden by the box from the view of the subject. The box will be open from the ends so that the subject can insert their hands into it. The hand which is more affected will be asked to hide behind the mirror. Intervention 2: Home dexterity program group: This group will perform the same exercises in the home dexterity program but without a mirror box. This protocol will be for 1 hour 3 times a week for 6 weeks. In this group, patients will perform these exercises either bi-manually or unimanual. Both hands have to be trained equally. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical Considerations
public Dr Saima Gul
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
Islamabad Pakistan 44000 +92 51 8441751 saimaa.gul@gmail.com Shifa Tameer e Millat University scientific Dr Saima Gul
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
Islamabad Pakistan 44000 +92 51 8441751 saimagul.ahs@stmu.edu.pk Shifa Tameer e Millat University Pakistan All patients with stages 1to 3 on Hoehn and Yahr scale and who would be on a stable medication regimen Patients with impaired hand dexterity 50 years 80 years Both Patients with history of other neurological conditions, Deep brain stimulation, Patients cognitive status < 24 Patients with visual field defects, which will prevent the patient to see their reflection of hand Patients with severe orthopedic conditions of upper limb. G-20 Idiopathic Parkinsonism or Parkinson's disease Rehabilitation Rehabilitation Mirror visual feedback therapy combined with home dexterity program group: This group will receive Mirror visual feedback therapy combined with a home-based dexterity Program for 1 hour 3 times a week for 6 weeks. A patient will have to perform six various types of exercises, either bi-manually or unimanual. Both hands will have to be trained equally. A mirror box will be used for the performance of Manual dexterity. A plastic foldable triangular box with an attached mirror on a side will be kept on a table so one of the hands of the subject will be reflected by the mirror and another hand will be hidden by the box from the view of the subject. The box will be open from the ends so that the subject can insert their hands into it. The hand which is more affected will be asked to hide behind the mirror. Home dexterity program group: This group will perform the same exercises in the home dexterity program but without a mirror box. This protocol will be for 1 hour 3 times a week for 6 weeks. In this group, patients will perform these exercises either bi-manually or unimanual. Both hands have to be trained equally. Hand dexterity. Timepoint: Baseline measurement and end of treatment. Method of measurement: Chedoke Arm and Hand Inventory. Hand strength. Timepoint: Baseline after intervention. Method of measurement: Hand held dynamometer. Reduced rate of tremors. Timepoint: Baseline after intervention. Method of measurement: Clinical rating scale for tremor. Hand dominance. Timepoint: Baseline after intervention. Method of measurement: Edinburgh handedness inventory. Shifa Tameer e Millat University Approved 2021-06-28 Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital. Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University Islamabad punjab Pakistan