NCT06485583

Brief Summary

To compare the efficacy of CIMT and NDT among stroke patients To study the phenomena of transfer of training To study relationship between the MMSE score and stroke rehabilitation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 25, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

June 25, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

(CIMT)(NDT)

Outcome Measures

Primary Outcomes (1)

  • upper extremity rehabilitation

    The Motor Assessment Scale (MAS) by Carr and Shepherd is a clinical tool used to evaluate upper extremity rehabilitation in stroke patients. It assesses motor recovery through eight items, each reflecting daily activities, scored on a 7-point scale from 0 (unable to perform) to 6 (optimal performance). For upper extremity assessment, the MAS includes tasks like hand movements (grasping, releasing, manipulating objects), advanced hand activities (fine motor skills such as writing or buttoning a shirt), and upper arm function (reaching, lifting, placing objects). Patients perform these tasks while clinicians observe and score their performance. The MAS provides a quantitative measure of motor recovery, facilitating progress tracking, goal setting, and personalized therapy interventions, making it a reliable and straightforward tool for capturing functional changes in stroke patients.

    6 WEEKS

Study Arms (2)

Constraint-Induced Movement Therapy

OTHER

The rehabilitation plan involves several components to promote the recovery of the affected limb. Initially, we will immobilize the unaffected limb using a constraint device such as a mitt or sling for about 90% of waking hours over a period of six weeks.

Other: Constraint-induced movement therapy

neurodevelopmental treatment

OTHER

The rehabilitation approach includes hands-on techniques to guide the patient through normal movement patterns. By providing sensory input, we aim to improve motor control and postural alignment, using techniques such as handling, guiding, and assisting movements.

Other: Neurodevelopmental Treatment

Interventions

is a rehabilitation technique used to improve motor function in people who have had a stroke or other neurological conditions. CIMT restricts the use of the unaffected limb, typically with a mitt or sling, to encourage the use of the affected limb.

Constraint-Induced Movement Therapy

Therapy, is a rehabilitation approach used to address movement and motor control deficits in people with neurological illnesses such as stroke, cerebral palsy, or traumatic brain injury.

neurodevelopmental treatment

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be aged 40-65 years and will have experienced either a hemorrhagic or ischemic stroke with hemiplegic presentation within the past 1 to 6 months. Additionally, they must have a Mini-Mental State Examination (MMSE) score of 23.

You may not qualify if:

  • Participants with visual or auditory deficits, musculoskeletal (MSK) disorders, mental impairments, or a history of surgery will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayesha Fatima

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 1. Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. The Lancet Neurology. 201514(2):224-34. 2. Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to Page 5 of 7 treat motor disorders. Progress in brain research. 2013207:379-401. 3. Budhota A, Chua KSG, Hussain A, Kager S, Cherpin A, Contu S, et al. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands. Frontiers in neurology. 202112:622014. 4. Folstein MF, Folstein SE, McHugh PR. Mini-mental state: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research. 197512(3):189-98. 5. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 198767(2):206-7. 6. Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 198565(2):175-80. 7. Ahn SY, Bok S-K, Lee JY, Ryoo HW, Lee HY, Park HJ, et al. Benefits of Robot-Assisted Upper-Limb Rehabilitation from the Subacute Stage after a Stroke of Varying Severity: A Multicenter Randomized Controlled Trial. Journal of Clinical Medicine. 202413(3):808. 8. Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, et al. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016315(6):571-81. 9. Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia. Developmental medicine and child neurology. 201153(4):313-20.

    BACKGROUND

MeSH Terms

Conditions

Thrombotic Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Ischemic StrokeStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 3, 2024

Study Start

June 28, 2024

Primary Completion

November 29, 2024

Study Completion

January 29, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations