Effects of Modified Constraint-Induced on Chronic Stroke Patients

Comparison of the Effect of Proprioceptive Training Therapy or Modified Constraint-Induced Movement Therapy on Upper Extremity Physical Functions in Chronic Stroke Patients - A Randomized Controlled Study

In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living activities in the upper extremity.

Study Overview

• Status: Completed
• Conditions: Stroke; Rehabilitation
• Intervention / Treatment: Other: conventional rehabilitation; Other: modified constraint-induced therapy; Other: Proprioceptive Training

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34752
    • Acibadem University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Post stroke hemiparetic patients of six months
• spasticity ≤ Grade -3 on modified Ashworth scale
• those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint
• a score of 24 or higher on the Modified Mini-Mental State Examination
• no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale

Exclusion Criteria:

• Patients with history of previous stroke,
• angina,
• uncontrolled hypertension, on medication that could impair neuromuscular performance,
• wrist or finger pathologies, significant visual or hearing impairment,
• balance problems which may compromise safety during sound upper limb constraint,
• unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: conventional rehabilitation	Other: conventional rehabilitation; Patients received conventional rehabilitation schedule
Experimental: Modified constraint-induced therapy	Other: modified constraint-induced therapy; Patients received conventional rehabilitation and modified constraint-induced therapy schedule
Experimental: Proprioceptive Training	Other: Proprioceptive Training; Patients received conventional rehabilitation and Proprioceptive Training schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer assessment test	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based upper extremity function. The maximum available score is 66 and The minimum available score is zero.The higher total score means better motor function in the arm	Score change after 6 weeks of intervention compared to baseline
Action Research arm test	The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance. The maximum available score from the 19 items was 57. The higher total score means better motor function in the arm	Score change after 6 weeks of intervention compared to baseline
Motor Activity Log	Daily use of the affected upper extremity was assessed using Motor Activity Log. It is a self-statement questionnaire to determine the frequency and quality of movement in the upper extremity. Score range is 0-5, The higher total score means better motor function in the arm	Score change after 6 weeks of intervention compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	Modified Ashworth Scale was measure muscle spasticity. It is among the most commonly used scales for clinical and research purposes. The resistance against passive movement is evaluated on a scale of 0-4 points.The lower total score means better spasticity in the arm	Score change after 6 weeks of intervention compared to baseline
thumb localizing test	A proprioception examination, called the 'thumb localizing test' (TLT), is described as a technique for testing 'limb localization'. With the patient's eyes closed, the examiner positions one of the patient's upper limbs (fixed limb) and asks him to pinch the thumb of that limb with the opposite thumb and index finger (reaching limb).It is evaluated on a 0-3 point scale. The lower the total score, the better the proprioceptive in the arm.	Score change after 6 weeks of intervention compared to baseline

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Modified constraint-induced therapy; Proprioceptive Training; conventional rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2020-24/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No