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

NCT05916885 | Completed DMC

• 1 other identifier: REC/RCR & AHS/23/0213
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhagic Stroke; Ischemic Stroke; Rehabilitation

Keywords

Hemorrhagic Stroke; Ischemic Stroke; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Wolf motor function test (WMF)

  Wolf motor function test (WMF) is a new time-based method for evaluating upper extremity performance that provides insight into joint-specific and whole limb movements. To investigates the effects of mandatory exercise therapy in patients with mild to moderate stroke and traumatic brain injury. The original version of the WMFT consisted of 21 items. The widely used WMFT consists of 17 items. The first 6 items consist of timed functional tasks, items 7 and 14 measure muscle strength, and the remaining 9 items consist of analyses of the quality of movement in accomplishing various tasks.

  9 months

• The motor activity log

  The motor activity log is a structured interview, designed to explore how and how well subjects are using the more affected arm outside of a laboratory setting. Participants are asked standardized questions about their high-impact arm usage (amount scale or AS) and quality of movement (how good scale or HW) during a specified functional activity. The scale is printed on a separate sheet and placed in front of the participant during test administration. Participants should be told that they can give half marks (i.e. 0.5, 1.5, 2.5, 3.5, 4.5) if this reflects their assessment.

  9 months

• The Ashworth scale,

  The Ashworth scale, which rates each passive movement between 1 (normal) and 5 (immobility), was used in a recent study and is easier to use than other methods and applicable to wide-range movements.

  9 months

Study Arms (2)

experimental group

EXPERIMENTAL

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

Other: short-intensity modified CIMT and conventional therapy

control group

ACTIVE COMPARATOR

a control group receiving conventional therapy alone.

Other: conventional therapy alone

Interventions

short-intensity modified CIMT and conventional therapy OTHER

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

experimental group

conventional therapy alone OTHER

a control group receiving conventional therapy alone.

control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 35326973 BACKGROUND

• 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.

  PMID: 34459426 BACKGROUND

• 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.

  PMID: 29163334 BACKGROUND

MeSH Terms

Conditions

Hemorrhagic Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Zeest Hashmi, MSNMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: November 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)