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Neurodevelopmental Technique Versus Mirror Therapy in Sub-acute Stroke Patients (NDTVSMT)

2026年7月28日 更新者:University of Lahore

Effects of Neurodevelopmental Technique Versus Mirror Therapy on Coordination, Functions and Ambulation in Sub-acute Hemiplegic Stroke Patients

As neurodevelopmental technique and mirror therapy had different effects on lower limb coordination, functions and ambulation. Both had proven to be helpful in the stroke patients to gain functional independency. Therefore, there was need to find out the best treatment approach either NDT, mirror therapy or both are equally effective to improve motor functions, coordination and ambulation of lower limb. This study would provide the health professionals the evidence to use best technique among these according to improvement in patients' coordination, function and ambulation.The study will be randomized clinical trial. This study will be conducted at the University of Lahore. A sample size of 40 will be randomly allocated by into two experimentals groups, (20 participants in each group), by the lottery method. All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group Neurodevelopmental technique, Group B: Experimental Group mirror therapy exercise) by lottery method. This study will be a single blinded study in which assessor will be blinded.

調査の概要

詳細な説明

The Neurodevelopmental Technique (NDT), also known as the Bobath concept, is a hands-on treatment approach focusing on normalizing movement patterns and reducing muscle tone abnormalities through guided and facilitated movement. It emphasizes postural control, alignment, and symmetrical movement to enhance motor recovery. Bobath approach works on the different types of movement dysfunctions and is based on the active involvement of the patients so that they can develop motor control. Manual handling is holding the patient at specific proprioceptive points, for example, joint compression and distraction, so that patients can respond actively to perform functions. Manual handling can be of different types and is slowly removed to make the patient independent in motor activities. This type of therapy incorporates improved functional control and independence. Mirror Therapy (MT), on the other hand, involves using a mirror to create a visual illusion of movement in the affected limb by reflecting the movements of the unaffected limb. This approach stimulates the brain's motor cortex and supports cortical reorganization through visual feedback, which may facilitate motor recovery and improve function Screening: Participants, will be referred by the Neuro Physician or Medicine Specialist of University of Lahore Teaching Hospital will be assessed for the eligibility criteria. Patients fulfilled the eligibility criteria will be asked to sign the consent forms before entering them to the study.

Recruitment: All the participants who will meet the criteria and sign the consent form will be recruited into the study.

Randomization and Allocation: All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group Neurodevelopmental technique, Group B: Experimental Group mirror therapy exercise) by lottery method.

Blinding: This study will be a single blinded study in which assessor will be blinded.

Intervention Routine Physical Therapy The treatment will start by routine physiotherapy (RPT) comprised of stretching and ROM in both experimental groups. In ROM following exercises including; hip (flexion, extension, abduction and adduction), knee (flexion, extension), ankle (plantarflexion, dorsiflexion, inversion, eversion and circumduction) and toe (flexion & extension). Stretching exercises included heel cord, gastrocnemius and hamstring stretch. Each ROM exercises were repeated 10 times with rest gap of 1 minute. Stretching exercises will repeated 5 times in one session and stretch will be held for 10 seconds. Time for RPT will be 20-25 minutes including rest intervals.

Group A: Experimental Group 1 (Neurodevelopmental technique with routine physical therapy) The participants randomly allocated in Group A will receive the neurodevelopmental therapy along with RPT. Exercises in NDT program will be performed in different positions: Supine position (Rotation of the trunk, Bridging, Flexion and extension of the knee and hip, Lowering the affected lower limb from the bed with hip extension and knee flexion, Pushing the wall with both limbs), Prone position (Mobilization of the ankle joint and functional stretching of gastro-soleus and quadriceps), Sitting position (Weight bearing on the affected side, reaching with trunk rotation, knee flexion-extension, Exercises of hip flexion and knee extension and Dorsi flexion of the ankle.), Standing position (standing with bearing weight on both legs, stepping to different directions, rising on toe, one leg standing). Each exercise will be 20 times per set in one session 2 minute rest between each set. The whole treatment session will start by 15 min warm up and end with 5 min cool down, and delivered 3 times a week for 12 weeks yielding a total of 36 sessions within 3 months and duration of each session will be of 65 minutes in Group A.

Group B: Experimental Group 2 (Mirror therapy with routine physical therapy) The participants randomly allocated in Group B will receive the mirror therapy. The experimental group will receive an additional 45 min of MT training. The patients will be instructed to remain in sitting position with a mirror (60 cm × 90 cm) will be positioned between the affected and healthy legs perpendicular to the subject's mid line. During the Mirror therapy, the reflecting side of the mirror will adjust to the non-affected leg and patients will be instructed to look at the reflection of the unaffected leg in the mirror as if it will the affected leg and perform bilateral symmetrical movements as much as possible. The practices will consist of heel raises (not holding on & sustained both separately), side stepping (not holding on & sustained both separately), single leg standing, leg movements i.e hip-knee-ankle flexion, knee extension with ankle dorsiflexion and ankle eversion. Each exercise will be 20 times per set in one session2 minute rest between each set. The whole treatment session will be delivered 3 times a week for 12 weeks yielding a total of 36 sessions within 3 months and duration of each session will be of 60-65 minutes in Group B. The whole treatment plan will be performed under strict observation for the familiarization of participants to ensure that each exercise will be performed by using correct technique.

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

研究連絡先のバックアップ

研究場所

    • Punjab Province
      • Lahore、Punjab Province、パキスタン、55150
        • 募集
        • University of Lahore Teaching Hospital
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Hafiza Sana Ashraf, MS-MSK

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
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

Age range between 45 to 65 years

  • Both genders
  • Sub-acute stroke hemiplegic cases; clinically stable, fully oriented and conscious.
  • Both ischemic and hemorrhagic patients were be included.
  • Patients with mini mental status examination (MMSE) (score > 23)

Exclusion Criteria:

  • Patients had recurrent stroke.
  • Any systemic conditions that limit functions such as; cardiac diseases (exertional dyspnea, angina, Myocardial Infarction, Pacemaker) Pulmonary diseases (Asthma, Pulmonary Fibrosis etc.), Diabatic neuropathy, Diabetic foot, Varicose veins etc
  • Other neurological conditions, such as; foot drop, muscular dystrophy, Myasthenia Gravis, Parkinsonism
  • Any visual and hearing problem
  • Any surgical and traumatic history of fractures, dislocations and/or brain injury due to any traumatic events.

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:Experimental: Neurodevelopmental Technique + Routine PT
Participants will receive Neurodevelopmental Technique (NDT) in supine, prone, sitting, and standing positions. Exercises include bridging, trunk rotation, hip/knee/ankle mobilization, bilateral weight bearing, stepping, and toe rise. Each exercise repeated 20 times per set with 2-minute rest between sets. Session duration: 65 minutes, three times per week, for 12 weeks (36 sessions total), in addition to routine physiotherapy.
Participants will perform Neurodevelopmental Technique (NDT) exercises in supine, prone, sitting, and standing positions. Activities include bridging, trunk rotation, hip/knee flexion-extension, ankle mobilization, bilateral weight bearing, stepping, toe rise, and single leg standing. Each exercise is performed 20 times per set with 2-minute rest intervals. Sessions last 65 minutes, three times per week, for 12 weeks (36 sessions), combined with routine physiotherapy.
アクティブコンパレータ:Active Comparator: Mirror Therapy + Routine PT
Participants will receive Mirror Therapy using a mirror (60×90 cm) placed midsagittal to reflect the unaffected leg. Bilateral symmetrical lower limb movements include heel raises, side stepping, single leg standing, hip/knee flexion-extension with ankle dorsiflexion, and ankle eversion. Each exercise repeated 20 times per set with 2-minute rest between sets. Session duration: 60-65 minutes, three times per week, for 12 weeks (36 sessions total), in addition to routine physiotherapy.

Patient sits with mirror (60×90 cm) reflecting unaffected leg. Performs bilateral symmetrical movements: heel raises, side stepping, single leg standing, hip/knee flexion-extension with ankle dorsiflexion, ankle eversion.

Each exercise 20× per set, 2 min rest between sets. 60-65 min/session, 3×/week, for 12 weeks (36 sessions).

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
Ambulation
時間枠:Baseline and Week 12

Ambulation will be assessed using the Six-Minute Walk Test (6MWT), which measures the distance a participant walks on a flat surface in six minutes.

Unit of Measure:- Meters

Baseline and Week 12
Lower Extremity Motor Function
時間枠:Baseline and Week 12
Lower extremity motor function will be assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE). Unit of Measure:- Total score (0-34)
Baseline and Week 12
Lower Limb Coordination
時間枠:Baseline and Week 12
Lower limb coordination will be assessed using the Lower Extremity Motor Coordination Test (LEMOCOT). Unit of Measure:- Number of target touches completed in 20 seconds
Baseline and Week 12

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Iqra Abdul Jabbar, MSPTN、Faculty of Allied Health Sciences, University Institute of Physical Therapy, University of Lahore
  • 主任研究者:Hafiza Sana Ashraf, MSPT MSK、Faculty of Allied Health Sciences, University Institute of Physical Therapy, University of Lahore

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)

2025年9月8日

一次修了 (推定)

2026年7月30日

研究の完了 (推定)

2026年8月15日

試験登録日

最初に提出

2025年9月11日

QC基準を満たした最初の提出物

2026年7月28日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8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7月28日

最終確認日

2026年2月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

I do not want

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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