Comparison of Frequency & Duration of Task Practice During Constraint Induced Movement Therapy

NCT04757467 | Completed DMC

• 1 other identifier: REC/00754 Sonia Hussain
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a very serious medical condition, classically categorized as a neurological disorder that occurs due to obstructed blood flow to specific parts of the brain, and resultant death of that area.This obstructed blood supply results in compromised function of that part of the brain, resulting in paralysis or interference with the normal function of the body controlled by that specific region of the brain. Stroke is usually of two types i.e. Ischemic and hemorrhagic. Ischemic stroke results in reduced or complete obstruction in blood flow in the vessels resulting in ischemia, while a hemorrhagic stroke occurs due to rupture of blood carrying vessels and results in clotting. CIMT has proven effective in rehabilitation of motor functions of lower limbs in many pieces of evidence but still, the evidence is less as compared to the upper extremity. Evidence about improvement in balance and gait using CIMT is very little. In some studies, hours of daily practice for the task has used as a total therapeutic dose measurement. While, in other studies, repetitions of the task have used to calculate the total amount of therapeutic intervention. This study will evaluate the effects of frequency and duration of the task in CIMT on motor functions, gait \& balance of lower limb stroke patients by intervention using these two protocols of CIMT.

Conditions

Stroke

Keywords

stroke; constraint induced movement therapy; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer assessment scale- lower extremity (FMA-LE)

  Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke. FMA scale has shown high validity and moderate to high reliability. Researches have shown stable responsiveness for this scale, lower extremity (maximum score of 34 points) are recommended as core measures to be used in every stroke recovery and rehabilitation trial.

  week 4

• Tinetti gait and balance test

  Tinetti Balance and Gate Test is a reliable and valid tool to measure gait ability in stroke patients. The Tinetti-gait and balance scale is a reliable and valid tool to measure gait ability in patients with chronic stroke. The inter-rater reliability of the Tinetti-gait scale is high. Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score

  week 4

Study Arms (3)

Standard physiotherapy neuro-rehabilitation

ACTIVE COMPARATOR

Control Group: Patients included in the control group will receive standard physiotherapy neurorehabilitation protocols.

Other: Standard physiotherapy neuro-rehabilitation

Repetition-CIMT

EXPERIMENTAL

In this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr

Other: Repetition-CIMT

Hour-CIMT

EXPERIMENTAL

The task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours.

Other: Hour-CIMT

Interventions

Standard physiotherapy neuro-rehabilitation OTHER

Treatment interventions which will be used for this group Passive range of movement exercises. Therapeutic positioning of the lower limb. Strengthening exercise for the lower limb. Over-ground gait training 5 times a week for 4 weeks. First week= 30 min exercise Second week= 1hour exercise Third week= 1hour and 30 min exercise Fourth week= 2 hours exercise All the treatment protocols will be applied to the patient for 5 times a week for consecutive 4 weeks. Interventions will be performed in the clinic and through home-based exercises using patient education

Standard physiotherapy neuro-rehabilitation

Repetition-CIMT OTHER

In this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr. * Sit-to-Stand * Forward and Backward stepping * Stair Climbing and Descending (only the first stair will be used) * Side-to-Side stepping with the affected limb Each task will be performed 10 times per session in the first week and 2 sessions a day. In the second week, each task will be performed 20 times per session for 2 sessions a day. In the third week, each task will be performed 30 times per session for 2 sessions a day.In the fourth week, each task will be performed 40 times per session for 2 sessions a day. The session will be held 5 days in a week for the period of consecutive 4 weeks. Total of 1000 repetitions of the above mentions tasks will be performed in 4 weeks' study time by every participant

Repetition-CIMT

Hour-CIMT OTHER

A task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours. (15) Sessions will be held 5 days in the week for a period of consecutive 4 weeks.

Hour-CIMT

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Stroke population (ACA)
• Lower limb impairment
• Ability to follow verbal and visual instructions
• No significant cognitive impairment (MMSE score ≥ 24)
• Moderate risk of fall (Tinetti gait and balance score 19-23).
• FMA-LE score of 21 or below out of 34

You may not qualify if:

• Other neurological conditions
• Lower limb impairment due to any other reason (fracture, diabetic neuropathy etc.)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university

Rawalpindi, Pakistan

Location

Related Publications (7)

• Warlow CP. Epidemiology of stroke. Lancet. 1998 Oct;352 Suppl 3:SIII1-4. doi: 10.1016/s0140-6736(98)90086-1. No abstract available.

  PMID: 9803954 BACKGROUND

• Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

  PMID: 23652265 BACKGROUND

• Sridharan SE, Unnikrishnan JP, Sukumaran S, Sylaja PN, Nayak SD, Sarma PS, Radhakrishnan K. Incidence, types, risk factors, and outcome of stroke in a developing country: the Trivandrum Stroke Registry. Stroke. 2009 Apr;40(4):1212-8. doi: 10.1161/STROKEAHA.108.531293. Epub 2009 Feb 19.

  PMID: 19228849 BACKGROUND

• Hartman-Maeir A, Soroker N, Oman SD, Katz N. Awareness of disabilities in stroke rehabilitation--a clinical trial. Disabil Rehabil. 2003 Jan 7;25(1):35-44.

  PMID: 12554390 BACKGROUND

• Fuzaro AC, Guerreiro CT, Galetti FC, Juca RB, Araujo JE. Modified constraint-induced movement therapy and modified forced-use therapy for stroke patients are both effective to promote balance and gait improvements. Rev Bras Fisioter. 2012 Apr;16(2):157-65. doi: 10.1590/s1413-35552012005000010. Epub 2012 Mar 1.

  PMID: 22378476 BACKGROUND

• Hakkennes S, Keating JL. Constraint-induced movement therapy following stroke: a systematic review of randomised controlled trials. Aust J Physiother. 2005;51(4):221-31. doi: 10.1016/s0004-9514(05)70003-9.

  PMID: 16321129 BACKGROUND

• Zipp GP, Winning S. Effects of constraint-induced movement therapy on gait, balance, and functional locomotor mobility. Pediatr Phys Ther. 2012 Spring;24(1):64-8. doi: 10.1097/PEP.0b013e31823e0245.

  PMID: 22207472 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayesha Afridi, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 17, 2021
• Study Start: August 1, 2020
• Primary Completion: February 20, 2021
• Study Completion: February 28, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)