NCT04468945

Brief Summary

The objective of the study is to determine the effects of Mirror therapy on upper limb function in a post-stroke patient, To determine the effects of Repetitive Facilitation Exercise on upper limb function in a post-stroke patient and To compare the effects of Mirror therapy versus Repetitive Facilitation Exercise on upper limb function in the post-stroke patient. Study Design is Randomized control trial with a sample size of 50 participants. Sampling Technique used is Non-probability purposive assessor-blinded sampling technique and randomization through sealed envelope method Duration of study was 6 months.Study Setting of Railway general hospital. Inclusion criteria had Hemiparetic patient, Sub-acute and chronic stroke patients, First-ever stroke patient, Age: 40-60, Gender: both male and female, MMSE \>24, Modified Ashworth scale \<3, Stable patient (Good sitting balance ) and No visual-spatial hemineglect. Exclusion criteria of Unstable patient, Uncooperative patient, Orthopedic deformity, Aphasia, Visual infection and joint pain (shoulder, elbow, wrist, hip, knee, ankle)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

July 8, 2020

Last Update Submit

September 7, 2020

Conditions

Keywords

Mirror therapyRepetitive Facilitation ExercisestrokeUpper limb

Outcome Measures

Primary Outcomes (4)

  • Fugal Meyer scale

    Fugl Meyer assessment tool is used for the evaluation of recovery extent in post stroke patients. It consists of 226 total points and is divided in 5 major domains including sensory function, motor function, joint range of motion, balance and pain each domain contain multiple sub items. Scoring is being recorded on a (3-points ordinal scale) . upper limb total score is 66. Fugyl Meyer is also a reliable and highly valid tool with ICC=0.96 and internal consistency is 94.7%.

    From baseline to 6th week

  • Wolf motor scale

    The Wolf motor scale is considered as numerical catalogue for the assessment of upper extremity motor function. Motor skills of patients are assessed through time and well designed, practical and functional tasks. Total 15 task has been performed. the minimum value for each task is 1 and maximum value is 3. increased value shows improvement.This is also a reliable tool for upper limb motor function with fair inter rater reliability as the value of ICC=0.97-0.99 and internal consistency is 92.4%.

    From baseline to 6th week

  • Upper extremity functional index

    Upper extremity functional index is use for outcome measure in stroke patient. It consist of 20-item questionnaire and each item has 5 point ordinal scale The total sum of all item the final score is 80 point. The reliability of upper extremity functional index is (ICC=0.94)

    From baseline to 6th week

  • Brunnstrom scale

    Brunnstrom recovery scale is use for motor recovery in stroke patient .It consist of 7-stages, 1=Flaccid Paralysis,2=Spasticity,3=Spasticity is marked ,4=Spasticity decreased,5= Spasticity wanes,6= Coordination and pattern of movement can be near normal ,7=Normal The inter-rater reliability if burnnstrom recovery scale is (ICC 0.89-0.98) for arm and (ICC 0.69-0.92)for hand.

    From baseline to 6th week

Study Arms (2)

mirror box therapy

EXPERIMENTAL

The objects use for task-specific mirror therapy are duster, glass, the wooden block of different sizes and shapes, beads, coin, paper cards and spongy ball. In all these activities shoulder horizontal flexion-extension, adduction-abduction, elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, finger flexion-extension, abduction, adduction, opposition, are performed automatically.

Other: mirror box therapy

Repetitive Facilitation Exercise

EXPERIMENTAL

Treatment involved rapid passive stretching of the muscles of the targeted joints in conjunction with tapping and rubbing the skin to assist in the generation of a contraction.Shoulder horizontal flexion-extension , adduction-abduction ,elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, finger flexion-extension, abduction, adduction, opposition, are performed

Other: Repetitive Facilitation Exercise

Interventions

* Patients in Task-specific mirror box therapy group will receive therapy for 30 min/day, 3 times/week for 6 weeks. * The patient is seated close to a table a mirror (33\*35 cm) was placed vertically. The involved hand was placed behind the mirror and uninvolved in front of the mirror. * The subject is asked to transfer small cubes from the middle position to the lateral side, placing pegs in holes and taking them out, turning over paper cards, placing steel needles in holes, stacking blocks, and putting glass on a shelf. * During the sessions, subjects will be asked to try and do the activity on the unaffected side and asked to do some movement with the paretic hand simultaneously.

mirror box therapy

* The patients in the control group will receive Repetitive Facilitation Exercise for 30 min/day, 3 times/week for 6 weeks. * Repetitive facilitative techniques were used to elicit movement of the shoulder, elbow, wrist, and fingers in a manner designed to minimize synergistic movements. * Participants were directed to concentrate on generating movement on the joint being treated while avoiding contraction of non-targeted muscles. * Therapists provided verbal directions with commands such as "bend/straighten" or "one, two, three. * Participant efforts were supplemented as necessary to achieve a full range of motion (ROM)

Repetitive Facilitation Exercise

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hemiparetic patient
  • Sub-acute and chronic stroke patients
  • First-ever stroke patient
  • Age: 40-60
  • Gender: both male and female
  • MMSE \>24
  • Modified Ashworth scale \<3
  • Stable patient (Good sitting balance )
  • No visual-spatial hemineglect.

You may not qualify if:

  • Unstable patient
  • Uncooperative patient
  • Orthopaedic deformity
  • Aphasia
  • Visual infection
  • Joint pain (shoulder, elbow, wrist, hip, knee, ankle)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 23652265BACKGROUND
  • Owolabi MO, Akarolo-Anthony S, Akinyemi R, Arnett D, Gebregziabher M, Jenkins C, Tiwari H, Arulogun O, Akpalu A, Sarfo FS, Obiako R, Owolabi L, Sagoe K, Melikam S, Adeoye AM, Lackland D, Ovbiagele B; Members of the H3Africa Consortium. The burden of stroke in Africa: a glance at the present and a glimpse into the future. Cardiovasc J Afr. 2015 Mar-Apr;26(2 Suppl 1):S27-38. doi: 10.5830/CVJA-2015-038.

    PMID: 25962945BACKGROUND
  • Yang Q, Tong X, Schieb L, Vaughan A, Gillespie C, Wiltz JL, King SC, Odom E, Merritt R, Hong Y, George MG. Vital Signs: Recent Trends in Stroke Death Rates - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Sep 8;66(35):933-939. doi: 10.15585/mmwr.mm6635e1.

    PMID: 28880858BACKGROUND
  • Scheid A, Choppin PW. Two disulfide-linked polypeptide chains constitute the active F protein of paramyxoviruses. Virology. 1977 Jul 1;80(1):54-66. doi: 10.1016/0042-6822(77)90380-4. No abstract available.

    PMID: 195398BACKGROUND
  • Shimodozono M, Noma T, Nomoto Y, Hisamatsu N, Kamada K, Miyata R, Matsumoto S, Ogata A, Etoh S, Basford JR, Kawahira K. Benefits of a repetitive facilitative exercise program for the upper paretic extremity after subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2013 May;27(4):296-305. doi: 10.1177/1545968312465896. Epub 2012 Dec 3.

    PMID: 23213077BACKGROUND
  • Riggs BL, Jowsey J, Kelly PJ, Arnaud CD. Role of hormonal factors in the pathogenesis of postmenopausal osteoporosis. Isr J Med Sci. 1976 Jul;12(7):615-9.

    PMID: 972016BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

July 15, 2019

Primary Completion

December 15, 2019

Study Completion

January 15, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations