Action Observation Therapy for Stroke

NCT04943601 | Completed DMC

• 1 other identifier: REC/00816 Zohaib
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a medical condition that causes the cessation of blood flow to the brain cells and eventually results in cell death. It's a condition that appears out of nowhere and has long-term implications. It is a common Global health-related problem that is disabling in nature and is the second common cause of death, leading to disability in the geriatric population worldwide. Most of the stroke affects the middle cerebral arteries that's why there will be more disability of upper limb, as compared to lower limb and loss of the upper limb function, is one of the most common deficits that a person experience after stroke. Action observation training can prime the motor system through the mirror neuron network that offers a mechanism for promoting neuroplasticity and reimbursement of motor control following stroke hemiparesis that would otherwise be restricted to use-dependent therapies.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (3)

• Fugel Meyer Assessment scale

  An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. The motor functioning for upper extremity is divided into 0 to 66 points and evaluates mobility, speed and coordination.

  week 4

• Box and block test

  This test is used to evaluate the manual dexterity of post-stroke patients. Box \& Block Test is composed of a wooden box with two equal compartments having 150 boxes in one compartment and the patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First, the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds

  week 4

• The Rating of Everyday Arm-use in the Community and Home (Reach) scale

  It is a self-report measure for patients with stroke and is classified into six categories that show progression from "no use" to "full use" of affected arm. This scale measures the functional recovery that incorporates whether the patient uses the affected arm in household activities and in community tasks.

  week 4

Study Arms (2)

Action observation training group

EXPERIMENTAL

The experimental group will receive a training program with Action observation by watching videos of complex tasks while imitating them. All the movements will be performed bilaterally so that regardless of the affected side the patient had the correct perspective to perform the exercise.

Other: action observation therapy

Conventional therapy group

ACTIVE COMPARATOR

The control group will receive conventional rehabilitation, with exercises of bimanual activities that will target their shoulder, elbow, wrist and finger joints similar to the experimental group but without Action observation

Other: conventional physical therapy

Interventions

action observation therapy OTHER

The participants will be three meters from the screen onto which the videos will be projected. The initial posture will vary depending on each movement, lying down, sitting, or standing and ensuring a clear field of vision. The sessions will be performed in groups of three to four patients

Action observation training group

conventional physical therapy OTHER

Verbal instructions will be given to perform and correct the movements requested. The sessions will be conducted in groups of three to four patients and all participants will have 3 to 4 assistants in the session, they will help them achieve their active-assisted range of motion requested in the exercises, when necessary.

Conventional therapy group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female both with age 40-75 years.
• Acute phase of stroke (\< 3 months)
• Without cognitive impairments (Mini-Mental State Examination \>23)
• No visual or auditory abnormalities
• Preserved visual acuity
• Middle cerebral artery infarction
• Fugl-Meyer assessment (FMA) score ≥20 for upper extremity status
• Dominant hand

You may not qualify if:

• Posterior circulation infarction(13)
• Comorbidities that influence voluntary upper-extremity function or multiple strokes.
• Apraxia and agnosia
• Cognitive defects or other neurological disorders

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rafsan Neuro Rehab Center

Peshawar, Pakistan

Location

Related Publications (7)

• Warlow C, van Gijn J, Dennis M, Wardlaw J, Bamford J. Stroke: practical management. 3rd edn, Peter L and Martin D editors. Oxford: Wiley-Blackwell; 2008.

  BACKGROUND

• Sale P, Ceravolo MG, Franceschini M. Action observation therapy in the subacute phase promotes dexterity recovery in right-hemisphere stroke patients. Biomed Res Int. 2014;2014:457538. doi: 10.1155/2014/457538. Epub 2014 May 22.

  PMID: 24967372 BACKGROUND

• Shelton FN, Reding MJ. Effect of lesion location on upper limb motor recovery after stroke. Stroke. 2001 Jan;32(1):107-12. doi: 10.1161/01.str.32.1.107.

  PMID: 11136923 BACKGROUND

• Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.

  PMID: 25416737 BACKGROUND

• Wallace AC, Talelli P, Dileone M, Oliver R, Ward N, Cloud G, Greenwood R, Di Lazzaro V, Rothwell JC, Marsden JF. Standardizing the intensity of upper limb treatment in rehabilitation medicine. Clin Rehabil. 2010 May;24(5):471-8. doi: 10.1177/0269215509358944. Epub 2010 Mar 17.

  PMID: 20237174 BACKGROUND

• Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.

  PMID: 31511706 BACKGROUND

• Borges LR, Fernandes AB, Oliveira Dos Passos J, Rego IAO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2022 Aug 5;8(8):CD011887. doi: 10.1002/14651858.CD011887.pub3.

  PMID: 35930301 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ayesha Afridi, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: December 1, 2020
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)