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Completed

NCT Number: NCT04873908

Effects of Modified Constraint-Induced on Chronic Stroke Patients

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem University

Istanbul, 34752, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

modified constraint-induced therapy

Other

Patients received conventional rehabilitation and modified constraint-induced therapy schedule

Proprioceptive training

Other

Patients received conventional rehabilitation and Proprioceptive Training schedule

conventional rehabilitation

Other

Patients received conventional rehabilitation schedule

Primary outcomes

  1. Fugl-Meyer assessment test

    Time frame: Score change after 6 weeks of intervention compared to baseline

    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

  2. Action Research arm test

    Time frame: Score change after 6 weeks of intervention compared to baseline

    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

  3. Motor Activity Log

    Time frame: Score change after 6 weeks of intervention compared to baseline

    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

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: Score change after 6 weeks of intervention compared to baseline

    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

  2. thumb localizing test

    Time frame: Score change after 6 weeks of intervention compared to baseline

    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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 5, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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