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Rhythmic Initiation vs Isometric Training for Arm Recovery After Stroke (RIITSTROKE)

2026年6月1日 更新者:Dr. Marium Zafar、University of Faisalabad

Comparative Effects of Rhythmic Initiation and Isometric Resistance Training on Upper Limb Motor Function, Strength, and Coordination in Subacute Stroke Patients

Stroke is a leading cause of long-term disability worldwide. Many stroke survivors experience persistent weakness, loss of motor control, and poor coordination in their upper limb, which limits their ability to perform daily activities and return to independent living. This study compares two physical therapy approaches for patients in the subacute stage of stroke recovery (1 to 6 months after stroke). The first approach is Rhythmic Initiation, a technique from Proprioceptive Neuromuscular Facilitation (PNF) that uses smooth, guided movement patterns progressing from passive to active movement. The second approach is Isometric Resistance Training, which involves holding static muscle contractions against resistance without moving the joint. The study will enroll 40 patients aged 40 to 60 years with unilateral upper limb weakness from a first-time stroke. Participants will be randomly assigned to receive either Rhythmic Initiation or Isometric Resistance Training for 30 minutes per session, 5 days per week, for 4 weeks. The researchers will measure changes in motor function, muscle strength, coordination, and spasticity before and after the 4-week intervention. The results will help physiotherapists understand which approach is more effective for upper limb rehabilitation in subacute stroke patients.

調査の概要

詳細な説明

This is a single-blind, parallel-arm, randomized clinical trial. Eligible participants will be recruited from Medina Teaching Hospital and The Canal Hospital in Faisalabad, Pakistan. Inclusion criteria include age 40-60 years, both genders, clinically diagnosed first-ever subacute stroke (1-6 months post-onset), and unilateral upper limb involvement. Exclusion criteria include severe spasticity (Modified Ashworth Scale >3), recurrent or bilateral stroke, shoulder subluxation or pain limiting movement, and cognitive or perceptual deficits. After providing written informed consent, participants will be randomly assigned in a 1:1 ratio to either Group A (Rhythmic Initiation) or Group B (Isometric Resistance Training). The randomization sequence will be generated using computer software, and allocation will be concealed in sealed opaque envelopes. The outcome assessor will be blinded to group assignment. Group A intervention: Rhythmic Initiation follows a four-step sequence-passive movement, active-assistive movement, active movement, and light resisted movement-using PNF diagonal patterns (D1 flexion/extension) for the affected upper limb. Each session lasts 30 minutes, 5 days per week for 4 weeks. The therapist emphasizes smooth rhythm and provides verbal cues throughout. Group B intervention: Isometric Resistance Training involves static contractions of major upper limb muscles including shoulder abductors, elbow flexors/extensors, and wrist flexors/extensors. Each contraction is held for 6 to 10 seconds at approximately 60-70% of maximum voluntary contraction. Participants perform 10 repetitions per muscle group, completing 3 sets. Rest periods of 30 to 60 seconds are provided between sets. Sessions last 30 minutes, 5 days per week for 4 weeks. Outcome measures are assessed at baseline (week 0) and after 4 weeks of intervention. The primary outcome is upper extremity motor function measured by the Fugl-Meyer Assessment Upper Extremity (FMA-UE) scale. Secondary outcomes include muscle strength measured by handheld dynamometry (shoulder, elbow, wrist), coordination measured by the timed finger-to-nose test, and spasticity measured by the Modified Ashworth Scale (MAS). Data will be analyzed using SPSS version 25. Paired t-tests will examine within-group changes from baseline to week 4. Independent t-tests will compare between-group differences. A p-value less than 0.05 will be considered statistically significant.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Dr Muhammad Ateeb, PhD Public Health
  • 電話番号:+923357333383
  • メール:mateeb.oric@tuf.edu.pk

研究連絡先のバックアップ

研究場所

    • Punjab Province
      • Faisalābad、Punjab Province、パキスタン、3800
        • 募集
        • The University of Faisalabad
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Clinically diagnosed subacute stroke (1 to 6 months post-onset)
  • Unilateral upper limb involvement
  • Age 40 to 60 years
  • Both genders
  • Medically stable and able to participate in physical therapy
  • Able to provide informed consent

Exclusion Criteria:

  • Severe spasticity (Modified Ashworth Scale score >3)
  • Recurrent or bilateral stroke
  • Shoulder subluxation
  • Shoulder or upper limb pain limiting active movement
  • Cognitive or perceptual deficits impairing ability to follow instructions
  • Other neurological disorder affecting upper limb (e.g., Parkinson's disease, multiple sclerosis)
  • Orthopedic condition affecting upper limb function

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Rhythmic Initiation Group
Participants receive Rhythmic Initiation technique for the affected upper limb. Each 30-minute session follows a sequence: passive movement, active-assistive movement, active movement, and light resisted movement using PNF diagonal patterns (D1 or D2). Sessions occur 5 days per week for 4 weeks.
What: Rhythmic Initiation technique from PNF. How: Therapist guides patient's affected upper limb through a four-step sequence-passive movement (therapist moves limb), active-assistive movement (patient helps with therapist assistance), active movement (patient moves independently), and light resisted movement (therapist adds gentle resistance). The movement follows PNF diagonal pattern D1 (flexion-adduction-external rotation to extension-abduction-internal rotation) or D2. Verbal cues emphasize smooth, rhythmic motion. When: 30 minutes per session, 5 days per week. How long: 4 weeks total. By whom: Trained physical therapist. Where: Outpatient rehabilitation department.
実験的:Isometric Resistance Training Group
Participants receive isometric strengthening exercises for upper limb muscles (shoulder abductors, elbow flexors/extensors, wrist flexors/extensors). Contractions held 6-10 seconds at 60-70% MVC, 10 repetitions × 3 sets. Sessions occur 30 minutes, 5 days/week for 4 weeks.
What: Isometric Resistance Training (static muscle contractions without joint movement). How: Patient contracts target muscle against resistance provided by therapist or stationary object. Target muscles include shoulder abductors, elbow flexors, elbow extensors, wrist flexors, and wrist extensors. Each contraction held 6-10 seconds at 60-70% of maximum voluntary contraction. Patient performs 10 repetitions per muscle group, completing 3 sets. Rest 30-60 seconds between sets. When: 30 minutes per session, 5 days per week. How long: 4 weeks total. By whom: Trained physical therapist. Where: Outpatient rehabilitation department.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Upper Extremity Motor Function
時間枠:Baseline (week 0) and post-intervention (week 4)
Measured by the Fugl-Meyer Assessment Upper Extremity (FMA-UE) scale. The FMA-UE evaluates motor function, sensation, coordination, and reflex activity in the upper limb. Scores range from 0 to 66, with higher scores indicating better motor function. The assessment is performed by a blinded outcome assessor.
Baseline (week 0) and post-intervention (week 4)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Upper Limb Muscle Strength
時間枠:Baseline (week 0) and post-intervention (week 4)
Measured using a handheld dynamometer. Maximum isometric strength recorded for shoulder abductors, elbow flexors, elbow extensors, wrist flexors, and wrist extensors. Three trials per muscle group; best score recorded in kilograms or Newtons.
Baseline (week 0) and post-intervention (week 4)
Change in Upper Limb Coordination
時間枠:Baseline (week 0) and post-intervention (week 4)
Measured by the timed finger-to-nose test. Patient seated, asked to alternately touch examiner's finger (held at shoulder height with arm fully extended) and then their own nose as quickly as possible. Time to complete 10 repetitions recorded in seconds.
Baseline (week 0) and post-intervention (week 4)
Change in Spasticity
時間枠:Baseline (week 0) and post-intervention (week 4)
Measured by the Modified Ashworth Scale (MAS). Spasticity graded from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension). Assessed at shoulder, elbow, and wrist.
Baseline (week 0) and post-intervention (week 4)

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月19日

一次修了 (実際)

2026年5月19日

研究の完了 (推定)

2026年6月24日

試験登録日

最初に提出

2026年5月13日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年6月1日

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