NCT04939493

Brief Summary

The purpose of the study is to determine the effect of rhythmic auditory cueing with bilateral arm training on upper limb functions in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

June 17, 2021

Last Update Submit

June 17, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessing the change in Upper Extremity Motor Performance

    Assessment via using Upper Extremity Motor Performance scale. This scale has been shown to be valid and reliable, and it correlates well with inter joint upper extremity coordination. It has a maximum score of 66

    Baseline and 6 weeks post-intervention

  • Assessing the change in upper limb Motor Function

    Assessment via using Wolf Motor Function Test (WMFT) The final time score will be the median time required for all timed tasks executed. One hundred twenty seconds is the maximum time allowed for each task attempted Timing is carried out using a stopwatch.

    Baseline and 6 weeks post-intervention

  • Assessing the change in gross manual dexterity

    Assessment via using Box and Block Test Involves moving 1-inch cube blocks from a rectangular box container to another container, and the number of blocks moved by each hand in 60 seconds is determined using stop watch

    Baseline and 6 weeks post-intervention

Study Arms (2)

Rhythmic Auditory Cueing

EXPERIMENTAL

Group (B): Patients in this group will receive the same designed physical therapy program given to the control group in addition to auditory cueing during bilateral arm training using the metronome.

Other: Rhythmic Auditory CueingOther: Bilateral arm trainingOther: Conventional physical therapy program

Bilateral arm training

ACTIVE COMPARATOR

Patients in this group will receive a standard physical therapy program in addition to Bilateral arm training.

Other: Bilateral arm trainingOther: Conventional physical therapy program

Interventions

Patients will perform the same movement sequence in time with the metronome beat. The frequency of the rhythmic auditory stimulation will be matched to the participant"s preferred movement speed, which will be assessed prior to the start of the trial, and participants typically started moving after they had heard the metronome beat two to three times. Participants will be given sufficient practice trials to ensure full understanding before the actual recording of data, and will be given 3-minutes break between trials. On the 3rd and 5th week, the rhythm frequency was increased by 5%.

Rhythmic Auditory Cueing

Training will consist of 20 minutes of bilateral arm training In each session, patients will be seated comfortably at a table in the following limb positions: ankles in neutral dorsiflexion, knees and hips placed at 90°, shoulders in 0° flexion, elbows in 60° flexion, and wrists in neutral position of flexion/extension

Bilateral arm trainingRhythmic Auditory Cueing

Scapular mobilization. Thoracic spine mobilization. Mechanical assisted (active and passive) exercises. Therapeutic positioning as weight bearing on the paretic arm. Opening and closing closed fist. Strengthening exercise. Stretching of spastic muscles.

Bilateral arm trainingRhythmic Auditory Cueing

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Thirty patients with ischemic stroke from both sexes will be included.
  • Patients will have stroke for the first time.
  • The age of patients will range from 45 to 60 years.
  • Duration of illness will be from six months to eighteen months.
  • The degree of spasticity will ranged from 1 to 1 + grade according to the modified Ashworth scale.
  • Patients will have moderate arm motor impairment (between 30 and 49 scores) according to Fugl-Meyer (FM) arm section scale.
  • The affected upper extremity will be the dominant side.
  • Patients will be able to sit and maintain balance in a sitting position.

You may not qualify if:

  • The patients will be excluded if they have:
  • Visual or auditory deficits.
  • Perceptual disorders.
  • Any surgical interventions in the upper extremities limiting the range of motion.
  • Aphasia or apraxia.
  • Musculoskeletal or neurological impairment of the unaffected upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, Egypt

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Reem Abdelhady

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 25, 2021

Study Start

January 1, 2021

Primary Completion

May 30, 2021

Study Completion

June 15, 2021

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations