Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.

NCT ID: NCT05916885

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-09-01

Brief Summary

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To determine effects of short-intensity modified constraint-induced movement therapy on hand function in stroke patients.

Detailed Description

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The aim of the study is to determine the effects of a short-intensity modified CIMT (mCIMT) program on hand function in stroke patients. This study will be a randomized controlled trial comprising two groups, an experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which participants will be given conventional therapy alone. Patients will be assessed with the Wolf Motor Function Test, the Motor Activity Log, and the Ashworth Scale before and after treatment. The data will be analyzed by using SPSS for windows software version 25. Statistical significance will be set at p=0.05.

Conditions

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Hemorrhagic Stroke Ischemic Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be allocated into two groups by randomization. The experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which patients will be given conventional therapy alone. The therapy regime will be 3 hours/ day, 5 days/week, and 4 successive weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

an experimental group receiving short-intensity modified CIMT and conventional therapy

Group Type EXPERIMENTAL

short-intensity modified CIMT and conventional therapy

Intervention Type OTHER

an experimental group receiving short-intensity modified CIMT and conventional therapy

control group

a control group receiving conventional therapy alone.

Group Type ACTIVE_COMPARATOR

conventional therapy alone

Intervention Type OTHER

a control group receiving conventional therapy alone.

Interventions

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short-intensity modified CIMT and conventional therapy

an experimental group receiving short-intensity modified CIMT and conventional therapy

Intervention Type OTHER

conventional therapy alone

a control group receiving conventional therapy alone.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients having the First stroke either ischemic or hemorrhagic (3-24 months after stroke)
* Patients having Mini-mental status examination score (MMSE) ≤23/30
* Patients having Passive range of motion (PROM) includes at least 90 degrees shoulder flexion and abduction, 45degrees shoulder external rotation,- 30 degrees elbow extension, and 45 degrees forearm supination and pronation (from a neutral position). At least 10 degrees active wrist extension, 10 degrees abduction/thumb extension, and 10-degree extension at the level of the metacarpophalangeal and interphalangeal joints between the two toes among the II-III-IV-V fingers (these movements will be repeated starting from a resting position 3 times in 1 minute).

Exclusion Criteria

* Patients having Subarachnoid hemorrhage.
* Patients having Motor activity log - the amount of use score ≥2.5
* Patients having treatment of upper limb spasticity (e.g., botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeest Hashmi, MSNMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Islamabad, Fedral, Pakistan

Site Status

Countries

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Pakistan

References

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Tedla JS, Gular K, Reddy RS, de Sa Ferreira A, Rodrigues EC, Kakaraparthi VN, Gyer G, Sangadala DR, Qasheesh M, Kovela RK, Nambi G. Effectiveness of Constraint-Induced Movement Therapy (CIMT) on Balance and Functional Mobility in the Stroke Population: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2022 Mar 8;10(3):495. doi: 10.3390/healthcare10030495.

Reference Type BACKGROUND
PMID: 35326973 (View on PubMed)

Uswatte G, Taub E, Lum P, Brennan D, Barman J, Bowman MH, Taylor A, McKay S, Sloman SB, Morris DM, Mark VW. Tele-rehabilitation of upper-extremity hemiparesis after stroke: Proof-of-concept randomized controlled trial of in-home Constraint-Induced Movement therapy. Restor Neurol Neurosci. 2021;39(4):303-318. doi: 10.3233/RNN-201100.

Reference Type BACKGROUND
PMID: 34459426 (View on PubMed)

Takebayashi T, Takahashi K, Moriwaki M, Sakamoto T, Domen K. Improvement of Upper Extremity Deficit after Constraint-Induced Movement Therapy Combined with and without Preconditioning Stimulation Using Dual-hemisphere Transcranial Direct Current Stimulation and Peripheral Neuromuscular Stimulation in Chronic Stroke Patients: A Pilot Randomized Controlled Trial. Front Neurol. 2017 Oct 30;8:568. doi: 10.3389/fneur.2017.00568. eCollection 2017.

Reference Type BACKGROUND
PMID: 29163334 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/23/0213

Identifier Type: -

Identifier Source: org_study_id

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