NCT06457022

Brief Summary

All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

First Submitted

Initial submission to the registry

June 8, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

25 days

First QC Date

June 8, 2024

Last Update Submit

July 18, 2024

Conditions

Keywords

Modified constraint induced movement therapyHemiparesisDual task trainingUpper extremityCognitive functions

Outcome Measures

Primary Outcomes (3)

  • Biodex isokinetic dynamometer

    Used to assess muscle strength and function

    4 weeks

  • Montreal cognitive assessment

    a quick test that is used to examine mild cognitive impairment and early dementia.

    4 weeks

  • Fugl Myer upper extremity

    a scale used to measure the functional impairment of stroke

    4 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Receiving modified constraint induced movement therapy , for 30 minutes , in addition to conventional physiotherapy program for the other 30 minutes.

Other: Modified Constraint Induced Movement therapyOther: Conventional physiotherapy rehabilitation program

Group B

EXPERIMENTAL

Receiving dual task training (Cognitive-Motor) for 30 minutes, in addition to conventional physiotherapy program for the other 30 minutes.

Other: Dual task training in the form of cognitive - motor taskOther: Conventional physiotherapy rehabilitation program

Group C

OTHER

Receiving only conventional physiotherapy program for 60 minutes.

Other: Conventional physiotherapy rehabilitation program

Interventions

patient wears a restraint instrument in his unaffected hand, then applying massed practice to his affected upper extremity. The patient wears padded glove in his unaffected upper extremity for restraining the patient from using his unaffected upper extremity for about 3 hours per day including the treatment session and the home program. So, by this way the patient is reinforced to use his affected upper extremity during this period of time to achieve his activities of daily living. Finally, the total time, the patient spends it during the day wearing the glove should be recorded each day.

Group A

Verbal fluency: Ask the hemiparetic patient to title many words of specific type as fruits, vegetable or animals. Mental tracking: as the hemiparetic patient to subtract serial 3 between number 90 and 100.

Group B

Ultrasound on shoulder. Graduated active exercises for shoulder. Prolonged stretching for spastic muscles

Group AGroup BGroup C

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with age range between 55 and 65 years old.
  • The patients were from both genders (males \&females).
  • Patients were of duration of illness between 6 and 12 months.
  • The patients were scoring 1 \&1+ on modified Ashworth scale (mild spasticity).
  • The patients were of good ability to see and hear.
  • Consent form was obtained from all participants to approve the study and follow the commands.
  • All patients were scoring more than 26 on MMSE. All patients were medically stable.

You may not qualify if:

  • patients with moderate and sever spasticity.
  • patients with cognitive disorder due to other cause rather than spasticity.
  • patients with unstable medical conditions.
  • patients with previous or recurrent stroke.
  • patients with respiratory problems.
  • patients with shoulder dislocation or subluxation or frozen shoulder.
  • patients with uncontrolled hypertension, diabetes mellitus, unstable angina or heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Neurology and it's Surgery

Study Record Dates

First Submitted

June 8, 2024

First Posted

June 13, 2024

Study Start

June 10, 2024

Primary Completion

July 5, 2024

Study Completion

July 10, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations